Sharing a Vision to Drive Healthcare Forward
Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources.
We are inspired by the potential ...
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- Contents
- Open Jobs
- Pharmaceutical Sales Lead - Centurion
- Systematic Literature Reviewer - Greece/Portugal/Spain/South Africa - Hybrid/Home-based - Centurion
- Medical Writer - Value Dossier - Greece/Portugal/Spain/South Africa - Hybrid/Home-based - Centurion
- Senior Site Activation Coordinator, Informed Consent Form LEAD - Bellville
- Associate Centralized Monitoring Lead - Sponsor Dedicated (Hybrid/Home-based) - Centurion
- Associate Centralized Monitoring Lead - Sponsor Dedicated (Hybrid/Home-based) - Bellville
- Associate Centralized Monitoring Lead - Sponsor Dedicated (Hybrid/Home-based) - Bloemfontein
- Engagement Manager – Public Health (French & English Bilingual)- Centurion
- Senior Proposals & Contracts Manager - Bloemfontein
- Global Study Leadership - Clinical Leads (South Africa) - Centurion
- Global Study Leadership - Clinical Leads (South Africa) - Bellville
- Global Study Leadership - Clinical Leads (South Africa) - Bloemfontein
- Senior Clinical Data Coder - Remote - Centurion
- Senior Clinical Data Coder - Remote - Bellville
- Senior Clinical Data Coder - Remote - Bloemfontein
- Senior Clinical Data Coder - Remote - Durban
- Key Accounts Manager - Pharma/Healthcare - Centurion
- Snr Data Management Lead, FSP, Homebased, South Africa - Bloemfontein
- Snr Data Management Lead, FSP, Homebased, South Africa - Bellville
- Snr Data Management Lead, FSP, Homebased, South Africa - Centurion
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Method of Application
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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Role overview
- In this role within the EMEA RW MEG you will be producing materials and services relating to the Health Economics Outcomes Research business areas (health economic modelling, evidence synthesis, statistical analysis, health technology assessment submissions, report and publication development for value communication) that generate value for our clients. The role of the Consultant is expected to play an important role in shaping the team’s literature review offerings.
The successful candidate:
- Will be involved in shaping and leading the team and offerings, working closely with the EMEA RWS Center of Excellence for Systematic Literature Review and the wider senior leadership team
- Has a good understanding of systematic literature methods (e.g., Cochrane)
- Can independently develop searches in various databases (e.g., EMBASE, MEDLINE, Cochrane, PubMed, etc.) and proficient in using OVID SP or another similar platform
- Keeps up to date on new methodologies and HTAs requirements for systematic literature reviews and be an in-house go-to expert for the team
- Has a good understand of different types of literature reviews (e.g., systematic, targeted, pragmatic, etc.)
- Managesliterature review projects with senior oversight
- Guides the team on interpretation/qualitative synthesis of the literature review findings
- Oversees literature review projects that meet rigorous HTA requirements, conducts quality control of literature review deliverables (searches, screening files, extractions, reporting)
- Is a day-to-day contact with clients who will include pharmaceutical, biotechnology and medical devices companies with global and regional headquarters based in the EMEA region, and occasionally their affiliate teams, with senior oversight
- Oversees the development of research questions, PICOS criteria, search strategies and literature review protocols
- Contributes to business development as well as internal initiatives for the advancement of innovative methodological approaches
- Collaborates with other business areas and functions of the organisation to deliver client services and support the development of new offerings
Qualifications and desired experience
- We are looking for a candidate with a good mix of academic and professional experience, domain experience and interpersonal skills. An ideal candidate has a good knowledge of literature review methods andhas experience in conducting rigorous literature reviews in health sciences. The ideal candidate will also have a good understanding of the typicalstructure of our clients from the pharmaceutical industry and how to successfully navigate this structure to achieve client’s aims.
- The list below should be viewed as a guide rather than a checklist. We want to prioritise recruiting candidates who will incorporate IQVIA’s value of ‘brave minds’ with their previous experience to put a personal spin on this role. If you share our passion for driving healthcare advancements through unparalleled data and have a passion for collaboration and solving complex problems, we encourage interested candidates who feel like they could be a good fit for the role to apply.
Desired skills and qualifications:
- Postgraduate degree level education or higher from a relevant discipline such as health or bioscience-related, medicine, biomedical sciences, health economics, health policy, epidemiology, public health, or information science
- Prior relevant experience, >2 years(such as, but not limited toexperience in systematic literature reviews and/or meta-analyses)
- Understanding of research principles, PRISMA principles, Cochrane guideline for SLRs, methods of the assessment of risk of bias for different study designs
- Understanding of the principles of evidence-based healthcare, critical appraisal and the interpretation and synthesis of health care research
- Understanding (and experience is advantageous) with the HTA agency requirements for evidence reviews and synthesis
- Excellent oral and written communication skills
- Accuracy, attention to detail and time management skills
- An understanding of meta-analysis methods is advantageous, but not essential
- Strong written and verbal communication skills with fluency in English
- Demonstrable commercial awareness and thorough understanding of the pharmaceutical industry is advantageous
- Proficiency in MS Word, PowerPoint, Excel
- Eligibility to work in one of our office locations without visa sponsorship
- Please submit your CV in English.
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Role purpose
- This role will offer you the opportunity to support our EMEAHealth Economics team as a ConsultantMedical Writer and be part of our HTA Evidence & StrategyCentre of Excellenceand Value Communications Centre of Excellence.
- This role focusses on medical writing for HEOR purposes, where you will be responsible forwriting tasks within HEOR projectsand work with a senior team to co-manage small workstreams, project tasks and thought leadership initiatives.Typical projectsinclude medical writing for the new EU Joint Clinical Assessment (JCA) dossier, HTA dossiers (e.g., NICE, SMC, NCPE, etc), global value dossiers, protocols and reports for literature reviews, reports for evidence synthesis and health economic modelling studies, andHEOR-focused peer-review manuscripts and conference abstracts. The audience for the project deliverables will be various life-sciences customers as well as healthcare payers, providers, and regulators.
- You will work within a team of highly experienced health economists and outcomes research specialists providing support across a range of HEOR projects, working in a cross-functional and cross-country project team, providing medical writing, undertaking quality control, and contributing to the management of project delivery (including guiding the work of more junior team members).
- The role will expose the candidate to the broad range of EMEA RWS offerings in value communications, HTA strategy and HEOR to support in business development opportunities.
- An ideal candidate will have a good understanding of the matrix structure typical of our clients from the pharmaceutical industry and how to successfully navigate this structure to achieve clients’ aims, as well as proven success in communicating scientific information in a strategic way to optimize a product’s access to markets and reimbursement.
Qualifications and Skills
- Previous experience with medical writing is essential for the role. We are looking for proactive individuals with strong analytical and problem-solving skills. Candidates should have a strategic mindset, the ability to identify potential issues and suggest solutions. The ideal applicant should have apt interpersonal skills and the ability to establish relationships with both internal team members and clients. As such, fluency in conversational and business English is essential. The ability to demonstrate this through slide deck development, report writing, and presentations is essential.
- We recruit individuals from a variety of backgrounds to join our well-rounded team. If you are motivated, have a passion for healthcare, and strong organisational skills and experience in medical writingwe encourage you to apply. The list below should be viewed as a guide rather than a checklist.
- Degree in life sciences (or related), epidemiology or health economics and policy, preferably a Master’sdegree;
- Significant experience in medical writing, including being the primary writeron peer-reviewed publications and HEOR study reports/protocols;
- Familiarity with health economics and health technology assessment is a benefit;
- Strong written and verbalEnglish communication skills, expertise in scientific writing requirements;
- Excellent Microsoft office skills (expert in use of MS Word), and high attention to detail;
- Self-motivated with a strong desire to learn quickly and independently, ability to work autonomously with appropriate guidancewhenneeded;
- Strong time-management and organisational skills, and flexibility to work in a fast-paced environment;
- Interest in data visualisation and presentation;
- Keen to work as a member of a diverse, multi-cultural team.
Responsibilities
- Write high-quality HEOR study reports and protocols, HTA/GVD dossiers, manuscripts, conference abstracts;
- Work with senior team to co-manage small workstreams, project tasks and thought leadership initiatives;
- Conduct quality control reviews of HEOR documents and maintaining audit trails of changes;
- Mentor and train less experienced Medical Writers;
- Contribute to medical writing training initiatives to upskill the team and set quality standards;
- Support the team’s Centre of Excellence initiatives.
- Please submit your CV in English.
go to method of application »
Role Overview
- As a Senior Site Activation Coordinator (ICF), you will oversee the development, review, and rollout of Informed Consent Forms across multiple countries and studies. You’ll partner with global and country teams, ensuring accuracy, compliance, and timely delivery.
What You’ll Do
- Lead and support ICF development (master & country level)
- Review ICFs for accuracy and protocol alignment
- Coordinate updates based on regulatory or guideline changes
- Track approvals and ensure timely execution of ICF documents
- Collaborate with sponsors and internal teams on project timelines
- Support and mentor country CSA specialists
- Act as a point of escalation for ICF‑related matters
What We’re Looking For
- Bachelor’s in Life Sciences or related field
- 3+ years’ experience in Life Sciences
- Strong communication, negotiation, and problem‑solving skills
- Ability to manage multiple projects
- Knowledge of ICH/GCP and regulatory requirements
go to method of application »
Job Overview
- Lead the execution of Centralized monitoring activities at multiple sites and studies from initiation through to closeout. Ensure that completion of work, clinical study management and project deliverables are on time and is in accordance with SOPs, policies and Good Clinical practices and applicable regulatory requirements.
- To provide CMS related support and assistance across multiple projects, sites and teams and review the structured clinical data output with access to medical charts.
- Adherence to protocol, overall completeness, and readiness of the supplied patient information to the next level of patient review and support the CMS leads in defining the metrics and timelines.
- Facilitate efficient and effective review of Site Visit Reports and assure consistent standards of implementation for quality to meet or exceed quality standards.
- Ensure subject safety, data integrity, escalation of issues and timely and responsive feedback in compliance with IQVIA SOP, ICH/ GCP guidelines, protocol requirements and regulatory compliance. Periodic review of site level KRIs and historic site performance according to Central Monitoring Plan.
Essential Functions
- Review Central Monitoring KRIs, Endpoint Analyses, Quality Tolerance Limits (QTLs), and other analyses on an ad hoc basis or as outlined in the study-specific Central Monitoring Plan (CMP)
- Minimum 1.5 yrs of Central Monitoring or Risk-based quality management Experience
- Collaborate effectively with study team
- Excellent Communication skills
- Manage assigned sites and perform Subject Level Data Review independently for multiple studies, if required perform with both responsibilities as dual role.;
- Perform remote monitoring visits for assigned sites as per requirement.;
- Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information as necessary to determine overall readiness of the patient information for next level review.;
- Perform Study specific analytics based on applicable study specific plans.; Contribute in developing new analytics proposal as per customer's demand, Ability to write analytical inferences to add business value and/or work on developing advanced analytics.;
- Manage the operational insight of the assigned project(s) and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.).;
- • Provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.;
- Adhere to customer roles and responsibilities or as activities defined per Scope Of Work
- Support CMS leads to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operations Plan.;
- Collaborate and support project resources (CRAs/ CTAs/Centralized Monitoring team).;
- Provide Mentorship to central monitors and CMA centralized monitoring associates.;
- Act as subject matter expert on one or more CMS specific activities/deliverables.;
- May lead study level efforts like automation of ISP, process enhancements, act as a POC for internal CM team and provide advice to the team.;
- Perform the IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labelling, Import/export licenses etc.).;
- Ensure complete and accurate documentation of all the study specific tools and templates and keep the project audit ready.;
- Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines.;
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information.;
- Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).;
- Perform the activities delegated and/or act as back up for/to relevant stakeholders including leads within the project team.;
- Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan and provide inputs to CMS leads to enable Early identification of site-level risk/issue(s).;
- Monitor site performance and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit).;
- Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed.;
- Work in accordance of the Study Central Monitoring Plan.;
- Establish and maintain effective project/ site level communications with relevant stakeholders.;
- Reviews reports per annotations, SOPs, guidelines etc., identifies issues and escalates the same to the Clinical Lead, prepares annotations and conducts CRA trainings, conducts monthly calls with relevant stakeholders to discuss major issues emerging from the trends noted during report review.;
- Review daily reports and prepare weekly/monthly reports and present it to Leadership Team, need to mentor and provide appropriate trainings to associates and attend study team meetings as needed or requested.;
- Act as a technical solution specialist (TSS) point of contact to connect with the project teams/internal stake holders for gathering the criteria and requirements.;
- Analyze the complexity of the requirements and provide the EAC hours and turnaround time.;
- Review of the Study Central Monitoring Plan
- Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested
- Adhere to the key activities outlined in the SOW as per customer requirements.
Qualifications
- Bachelor's Degree Clinical, life sciences, mathematical sciences, or related field, or nursing qualification Req
- Minimum of 3 years of relevant work experience or equivalent combination of education, training and experience.
- Experience in clinical research field preferred. Pref
- Good knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
- Good Clinical system expertise.
- Strong written and verbal communication skills including good command of English language.
- Results and detail-oriented approach to work delivery and output.
- Understanding of clinical/medical data.
- Good motivational, influencing, coaching skills.
- Ability to work on multiple projects and manage competing priorities. In depth therapeutic and protocol knowledge.
- Strong organizational and problem-solving skills.
- Effective presentation skills.
- Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
- Ability to work across cultures and geographies with a high awareness and understanding of cultural differences and maintain effective working relationships with coworkers, managers and clients.
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Regular sitting for extended periods of time.
go to method of application »
Job Overview
- Lead the execution of Centralized monitoring activities at multiple sites and studies from initiation through to closeout. Ensure that completion of work, clinical study management and project deliverables are on time and is in accordance with SOPs, policies and Good Clinical practices and applicable regulatory requirements.
- To provide CMS related support and assistance across multiple projects, sites and teams and review the structured clinical data output with access to medical charts.
- Adherence to protocol, overall completeness, and readiness of the supplied patient information to the next level of patient review and support the CMS leads in defining the metrics and timelines.
- Facilitate efficient and effective review of Site Visit Reports and assure consistent standards of implementation for quality to meet or exceed quality standards.
- Ensure subject safety, data integrity, escalation of issues and timely and responsive feedback in compliance with IQVIA SOP, ICH/ GCP guidelines, protocol requirements and regulatory compliance. Periodic review of site level KRIs and historic site performance according to Central Monitoring Plan.
Essential Functions
- Review Central Monitoring KRIs, Endpoint Analyses, Quality Tolerance Limits (QTLs), and other analyses on an ad hoc basis or as outlined in the study-specific Central Monitoring Plan (CMP)
- Minimum 1.5 yrs of Central Monitoring or Risk-based quality management Experience
- Collaborate effectively with study team
- Excellent Communication skills
- Manage assigned sites and perform Subject Level Data Review independently for multiple studies, if required perform with both responsibilities as dual role.;
- Perform remote monitoring visits for assigned sites as per requirement.;
- Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information as necessary to determine overall readiness of the patient information for next level review.;
- Perform Study specific analytics based on applicable study specific plans.; Contribute in developing new analytics proposal as per customer's demand, Ability to write analytical inferences to add business value and/or work on developing advanced analytics.;
- Manage the operational insight of the assigned project(s) and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.).;
- • Provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.;
- Adhere to customer roles and responsibilities or as activities defined per Scope Of Work
- Support CMS leads to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operations Plan.;
- Collaborate and support project resources (CRAs/ CTAs/Centralized Monitoring team).;
- Provide Mentorship to central monitors and CMA centralized monitoring associates.;
- Act as subject matter expert on one or more CMS specific activities/deliverables.;
- May lead study level efforts like automation of ISP, process enhancements, act as a POC for internal CM team and provide advice to the team.;
- Perform the IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labelling, Import/export licenses etc.).;
- Ensure complete and accurate documentation of all the study specific tools and templates and keep the project audit ready.;
- Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines.;
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information.;
- Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).;
- Perform the activities delegated and/or act as back up for/to relevant stakeholders including leads within the project team.;
- Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan and provide inputs to CMS leads to enable Early identification of site-level risk/issue(s).;
- Monitor site performance and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit).;
- Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed.;
- Work in accordance of the Study Central Monitoring Plan.;
- Establish and maintain effective project/ site level communications with relevant stakeholders.;
- Reviews reports per annotations, SOPs, guidelines etc., identifies issues and escalates the same to the Clinical Lead, prepares annotations and conducts CRA trainings, conducts monthly calls with relevant stakeholders to discuss major issues emerging from the trends noted during report review.;
- Review daily reports and prepare weekly/monthly reports and present it to Leadership Team, need to mentor and provide appropriate trainings to associates and attend study team meetings as needed or requested.;
- Act as a technical solution specialist (TSS) point of contact to connect with the project teams/internal stake holders for gathering the criteria and requirements.;
- Analyze the complexity of the requirements and provide the EAC hours and turnaround time.;
- Review of the Study Central Monitoring Plan
- Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested
- Adhere to the key activities outlined in the SOW as per customer requirements.
Qualifications
- Bachelor's Degree Clinical, life sciences, mathematical sciences, or related field, or nursing qualification Req
- Minimum of 3 years of relevant work experience or equivalent combination of education, training and experience.
- Experience in clinical research field preferred. Pref
- Good knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
- Good Clinical system expertise.
- Strong written and verbal communication skills including good command of English language.
- Results and detail-oriented approach to work delivery and output.
- Understanding of clinical/medical data.
- Good motivational, influencing, coaching skills.
- Ability to work on multiple projects and manage competing priorities. In depth therapeutic and protocol knowledge.
- Strong organizational and problem-solving skills.
- Effective presentation skills.
- Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
- Ability to work across cultures and geographies with a high awareness and understanding of cultural differences and maintain effective working relationships with coworkers, managers and clients.
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Regular sitting for extended periods of time.
go to method of application »
Job Overview
- Lead the execution of Centralized monitoring activities at multiple sites and studies from initiation through to closeout. Ensure that completion of work, clinical study management and project deliverables are on time and is in accordance with SOPs, policies and Good Clinical practices and applicable regulatory requirements.
- To provide CMS related support and assistance across multiple projects, sites and teams and review the structured clinical data output with access to medical charts.
- Adherence to protocol, overall completeness, and readiness of the supplied patient information to the next level of patient review and support the CMS leads in defining the metrics and timelines.
- Facilitate efficient and effective review of Site Visit Reports and assure consistent standards of implementation for quality to meet or exceed quality standards.
- Ensure subject safety, data integrity, escalation of issues and timely and responsive feedback in compliance with IQVIA SOP, ICH/ GCP guidelines, protocol requirements and regulatory compliance. Periodic review of site level KRIs and historic site performance according to Central Monitoring Plan.
Essential Functions
- Review Central Monitoring KRIs, Endpoint Analyses, Quality Tolerance Limits (QTLs), and other analyses on an ad hoc basis or as outlined in the study-specific Central Monitoring Plan (CMP)
- Minimum 1.5 yrs of Central Monitoring or Risk-based quality management Experience
- Collaborate effectively with study team
- Excellent Communication skills
- Manage assigned sites and perform Subject Level Data Review independently for multiple studies, if required perform with both responsibilities as dual role.;
- Perform remote monitoring visits for assigned sites as per requirement.;
- Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information as necessary to determine overall readiness of the patient information for next level review.;
- Perform Study specific analytics based on applicable study specific plans.; Contribute in developing new analytics proposal as per customer's demand, Ability to write analytical inferences to add business value and/or work on developing advanced analytics.;
- Manage the operational insight of the assigned project(s) and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.).;
- • Provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.;
- Adhere to customer roles and responsibilities or as activities defined per Scope Of Work
- Support CMS leads to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operations Plan.;
- Collaborate and support project resources (CRAs/ CTAs/Centralized Monitoring team).;
- Provide Mentorship to central monitors and CMA centralized monitoring associates.;
- Act as subject matter expert on one or more CMS specific activities/deliverables.;
- May lead study level efforts like automation of ISP, process enhancements, act as a POC for internal CM team and provide advice to the team.;
- Perform the IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labelling, Import/export licenses etc.).;
- Ensure complete and accurate documentation of all the study specific tools and templates and keep the project audit ready.;
- Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines.;
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information.;
- Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).;
- Perform the activities delegated and/or act as back up for/to relevant stakeholders including leads within the project team.;
- Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan and provide inputs to CMS leads to enable Early identification of site-level risk/issue(s).;
- Monitor site performance and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit).;
- Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed.;
- Work in accordance of the Study Central Monitoring Plan.;
- Establish and maintain effective project/ site level communications with relevant stakeholders.;
- Reviews reports per annotations, SOPs, guidelines etc., identifies issues and escalates the same to the Clinical Lead, prepares annotations and conducts CRA trainings, conducts monthly calls with relevant stakeholders to discuss major issues emerging from the trends noted during report review.;
- Review daily reports and prepare weekly/monthly reports and present it to Leadership Team, need to mentor and provide appropriate trainings to associates and attend study team meetings as needed or requested.;
- Act as a technical solution specialist (TSS) point of contact to connect with the project teams/internal stake holders for gathering the criteria and requirements.;
- Analyze the complexity of the requirements and provide the EAC hours and turnaround time.;
- Review of the Study Central Monitoring Plan
- Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested
- Adhere to the key activities outlined in the SOW as per customer requirements.
Qualifications
- Bachelor's Degree Clinical, life sciences, mathematical sciences, or related field, or nursing qualification Req
- Minimum of 3 years of relevant work experience or equivalent combination of education, training and experience.
- Experience in clinical research field preferred. Pref
- Good knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
- Good Clinical system expertise.
- Strong written and verbal communication skills including good command of English language.
- Results and detail-oriented approach to work delivery and output.
- Understanding of clinical/medical data.
- Good motivational, influencing, coaching skills.
- Ability to work on multiple projects and manage competing priorities. In depth therapeutic and protocol knowledge.
- Strong organizational and problem-solving skills.
- Effective presentation skills.
- Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
- Ability to work across cultures and geographies with a high awareness and understanding of cultural differences and maintain effective working relationships with coworkers, managers and clients.
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Regular sitting for extended periods of time.
go to method of application »
Roles and Responsibilities
A lead is expected to contribute to the firm's growth and development in a variety of ways, including:
- Delivery Excellence: Understand client requirements, project scope and deliverables; Lead project delivery and client meetings under overall guidance of Senior management; follow Assess-Design-Develop-Deliver-Monitor process in various work modules of the project; project team management and coordination with internal and external stakeholders etc. Also, would manage vendor, Design & Delivery and Data Processing, maintain field schedules, monitoring and communicating deadlines to team; checking programmed questionnaires; monitoring and maintaining progress of fieldwork; specifying deliverable requirements; final review of member deliverables. Contribute to team process improvements.
- Operational excellence: Ensuring project profitability, timely delivery of projects, invoicing and collection, quality & risk management, positive feedbacks from the client, etc.
- Business Development: Identification and development of work opportunities, client requirement analysis, development of EoI/proposals, client presentations, etc.Practice Development: Support and lead learning and development initiatives for the team/project/organization.
- Thought Leadership: Manage research, analysis and delivery of thought leadership reports (global and domestic) with guidance from senior team professionals.
- As lead, the primary role would be to manage & lead project work streams/modules and client interactions with support from Sr. consultants/ Consultants in team. Additionally, you would be coaching team on technical and management areas.
Language competency
- English: minimum C1 level
- French: minimum C1 level
- Portuguese: B2 level or more would be an advantage
Post-Graduation:
- Master’s in Public Health / Health Administration / Social Sciences / Business Administration/ Economics/ Public Policy / international development,
- Graduation: Any (MBBS/BHMS is desirable)
- Should have relevant experience of 12+ years with a minimum of 5 years in mid-level management roles
- Prior consulting / advisory experience in public health sector in Africa is a highly desirable
- Prior experience of managing large scale projects for government clients and donor agencies
- Excellent project management skills with effective communication and team-management skills
- Strong attention to details, critical and problem-solving skills
- Report writing and PowerPoint development skills
- Excellent understanding of the global health sector
- Willingness to travel and adaptability to change
- Stay informed about research and global trends in our program areas to inform our strategy accordingly.
- Network with other institutions running similar programs to find areas of collaboration and knowledge sharing
go to method of application »
Position Summary
- The Senior Proposals & Contracts Manager is primarily responsible for leading end‑to‑end proposal development activities for assigned customers, including complex and strategic bids. The role plays a critical part in shaping high‑quality, competitive proposals that support business growth and customer success.
- Contract‑related activities are part of the role but are secondary and primarily linked to proposal and bid processes. Acting as a regional subject‑matter expert for proposals, this position partners closely with Sales and cross‑functional teams to ensure consistency, efficiency, and customer satisfaction across all proposal activities.
Key Responsibilities
Proposal Development & Bid Management
- Lead, coordinate, and manage end‑to‑end proposal development for complex, strategic, and high‑value customer opportunities.
- Develop proposal strategies, timelines, and response structures in collaboration with Sales and internal stakeholders.
- Coordinate cross‑functional inputs (Finance, Operations, Legal, Medical, etc.) to deliver accurate, compliant, and competitive proposals.
- Support pricing, costing, and budget development aligned with proposal strategy and customer requirements.
- Participate in bid defenses, customer presentations, and negotiations as required.
Contract Support & Review
- Support the review and negotiation of contracts, including Master Service Agreements (MSAs) and amendments, as part of proposal and bid activities.
- Ensure contractual documentation aligns with approved proposal assumptions, internal policies, and governance requirements.
- Liaise with Legal and other stakeholders to escalate and resolve complex contractual topics when needed.
Customer & Stakeholder Engagement
- Act as the primary internal point of contact for proposal‑related activities for assigned customers.
- Build and maintain strong, trust‑based relationships with internal and external stakeholders.
- Serve as a regional subject‑matter expert for proposal processes, ensuring consistency in approach, metrics, and documentation standards.
Process Improvement & Strategic Contribution
- Identify risks, gaps, and inefficiencies in proposal processes and proactively drive improvements.
- Contribute to the development and continuous enhancement of proposal tools, templates, and best practices.
- Provide strategic input on proposal‑related initiatives with minimal supervision.
Collaboration & Mentorship
- Provide guidance, coaching, and technical support to colleagues within the proposals function.
- Collaborate closely with Sales, Finance, Legal, Operations, and other internal teams to support successful bid outcomes.
Compliance & Knowledge Expertise
- Maintain strong knowledge of proposal systems, processes, and governance frameworks.
- Ensure proposal and associated contract activities comply with internal procedures and applicable regulations.
- Perform additional duties as assigned.
Qualifications
Education & Experience
- Bachelor’s degree in Life Sciences, Business Administration, or a related field.
- Minimum of 7 years of experience in proposal development, bid management, or a closely related commercial role, preferably within the CRO industry.
- Contract experience is considered an advantage but is not required as a primary area of specialization.
Technical & Professional Skills
- Strong experience leading complex proposals and coordinating cross‑functional bid teams.
- Advanced proficiency in Microsoft Excel and Word, including costing and pricing models.
- Ability to interpret customer requirements, clinical protocols, budgets, and financial assumptions.
- Strong commercial and analytical mindset.
Key Competencies
- Excellent organizational, analytical, and problem‑solving skills.
- Strong verbal and written communication skills.
- Ability to manage multiple complex proposals simultaneously under tight timelines.
- Proven ability to build effective relationships with customers and internal stakeholders.
go to method of application »
Job Overview
- Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster.
- The Clinical Lead is a member of the core project team responsible for the clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Clinical Leads ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams ensuring projects meet delivery requirements at all times.
Essential Functions
- Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
- Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
- Contribute to the development of the project risk mitigation plan and manage clinical risks through the project’s lifecycle.
- Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
- Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.
- Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
- Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
- Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
- Conduct regular team meetings and communicate appropriately to achieve objectives.
- Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.
- May contribute to the development of the clinical delivery strategy for proposals. Participate in bid defense preparations and meetings. Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership.
- May mentor and coach new peers as they assimilate into this role.
- May work as a primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
- May attend site visits as applicable in support of project delivery.
Qualifications
- Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required.
- Requires 5 years clinical research/monitoring experience or equivalent combination of education, training and experience.
- Requires basic knowledge of Project management practices and terminology.
- Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.; Req
- Requires broad protocol knowledge and therapeutic knowledge.;
- Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates. Req
- Requires understanding of project finances.
- Knowledge of clinical trials - Knowledge of clinical trial conduct in addition to skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.
go to method of application »
Job Overview
- Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster.
- The Clinical Lead is a member of the core project team responsible for the clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Clinical Leads ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams ensuring projects meet delivery requirements at all times.
Essential Functions
- Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
- Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
- Contribute to the development of the project risk mitigation plan and manage clinical risks through the project’s lifecycle.
- Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
- Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.
- Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
- Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
- Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
- Conduct regular team meetings and communicate appropriately to achieve objectives.
- Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.
- May contribute to the development of the clinical delivery strategy for proposals. Participate in bid defense preparations and meetings. Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership.
- May mentor and coach new peers as they assimilate into this role.
- May work as a primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
- May attend site visits as applicable in support of project delivery.
Qualifications
- Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required.
- Requires 5 years clinical research/monitoring experience or equivalent combination of education, training and experience.
- Requires basic knowledge of Project management practices and terminology.
- Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.; Req
- Requires broad protocol knowledge and therapeutic knowledge.;
- Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates. Req
- Requires understanding of project finances.
- Knowledge of clinical trials - Knowledge of clinical trial conduct in addition to skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.
go to method of application »
Job Overview
- Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster.
- The Clinical Lead is a member of the core project team responsible for the clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Clinical Leads ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams ensuring projects meet delivery requirements at all times.
Essential Functions
- Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
- Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
- Contribute to the development of the project risk mitigation plan and manage clinical risks through the project’s lifecycle.
- Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
- Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.
- Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
- Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
- Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
- Conduct regular team meetings and communicate appropriately to achieve objectives.
- Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.
- May contribute to the development of the clinical delivery strategy for proposals. Participate in bid defense preparations and meetings. Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership.
- May mentor and coach new peers as they assimilate into this role.
- May work as a primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
- May attend site visits as applicable in support of project delivery.
Qualifications
- Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required.
- Requires 5 years clinical research/monitoring experience or equivalent combination of education, training and experience.
- Requires basic knowledge of Project management practices and terminology.
- Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.; Req
- Requires broad protocol knowledge and therapeutic knowledge.;
- Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates. Req
- Requires understanding of project finances.
- Knowledge of clinical trials - Knowledge of clinical trial conduct in addition to skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.
go to method of application »
Job Overview
- Manage single and multi-service projects, ensuring quality deliverables on time, within budget and to the customer’s satisfaction; Provide expert skills as part of a Clinical Data Management (CDM) team to provide quality data that meet customer needs; Provide leadership to the team in the area of coding, project planning and execution, financial management, communication and milestone tracking; Viewed as an expert in coding of clinical data.
Essential Functions
- Serve as an account lead, or internal or external point of contact on standalone coding studies or accounts
- Maintain post-coding dictionary up-versioning synonym and coding reconciliation to align coding to latest dictionary versions.
- Perform Dictionary up-versioning activities.
- Perform external verbatim coding of data from non-EDC sources in line with required coding dictionary versions.
- Manage the customer relationship for the project team including active participation in coding related customer negotiation on timeline, budgetary and other issues
- Provide support to lead coders on one or more large global studies
- Manage the relationship with a customer
- Serve independently as a Lead Data Coder and/or Coding reviewer for one or more projects
- May serve as a DOC or DTL for one or more projects
- Perform comprehensive quality control procedures
- Perform Serious Adverse Event (SAE) coding reconciliation activities
- Collaborate with customers and develop solutions and action plans for issues, escalations and road blocks
- Proactively identify, solve quality issues and deliver projects as per agreed timeline
- Identify and provide due diligence for out of scope activity
- Manage resource capacity for the project team
- Mentor other team members in training and developing coding expertise
- Independently bring project solutions to the Coding and CDM team
- Identify and implement processes and quality improvement initiatives in the DM and coding function
- Developing and implementing best practices in the team
- Manage the development and implementation of new technologies
- Demonstrate scientific and research temperament by presenting at, or participating in local and international forums
- Responsible for identifying and implementing process improvements using established methods (principles of lean and six sigma) in collaboration with experts
- Provide review and expert opinion in developing, revising, and maintaining standard core operating procedures and work instructions
- Perform other duties as directed by the DOC, DTL or Manager, or meet objectives as assigned
- Develop and maintain good communications and working relationships with the CDM team and client stakeholders
Qualifications and experience
- High School Diploma or equivalent Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent Pref
- 7 years relevant experience in clinical trials within a similar function, including proven competence in managing the delivery of coding or/and other data management processes for multiple global projects, also including experience in handling complex customer negotiations and bid defense meeting.
- 5 years thesaurus management experience is essential
- Excellent knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHODD, ICD9, etc.).
- Excellent knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology required for many tasks.
- Advanced knowledge of data management processes and systems and advanced ability to apply this knowledge in practice.
- Excellent understanding of clinical drug development process (detail oriented).
- Good project management skills related to all phases of clinical studies.
- Excellent knowledge of operating procedures and work instructions and the ability to apply them in practice.
- Excellent English written and oral communication skills.
go to method of application »
Job Overview
- Manage single and multi-service projects, ensuring quality deliverables on time, within budget and to the customer’s satisfaction; Provide expert skills as part of a Clinical Data Management (CDM) team to provide quality data that meet customer needs; Provide leadership to the team in the area of coding, project planning and execution, financial management, communication and milestone tracking; Viewed as an expert in coding of clinical data.
Essential Functions
- Serve as an account lead, or internal or external point of contact on standalone coding studies or accounts
- Maintain post-coding dictionary up-versioning synonym and coding reconciliation to align coding to latest dictionary versions.
- Perform Dictionary up-versioning activities.
- Perform external verbatim coding of data from non-EDC sources in line with required coding dictionary versions.
- Manage the customer relationship for the project team including active participation in coding related customer negotiation on timeline, budgetary and other issues
- Provide support to lead coders on one or more large global studies
- Manage the relationship with a customer
- Serve independently as a Lead Data Coder and/or Coding reviewer for one or more projects
- May serve as a DOC or DTL for one or more projects
- Perform comprehensive quality control procedures
- Perform Serious Adverse Event (SAE) coding reconciliation activities
- Collaborate with customers and develop solutions and action plans for issues, escalations and road blocks
- Proactively identify, solve quality issues and deliver projects as per agreed timeline
- Identify and provide due diligence for out of scope activity
- Manage resource capacity for the project team
- Mentor other team members in training and developing coding expertise
- Independently bring project solutions to the Coding and CDM team
- Identify and implement processes and quality improvement initiatives in the DM and coding function
- Developing and implementing best practices in the team
- Manage the development and implementation of new technologies
- Demonstrate scientific and research temperament by presenting at, or participating in local and international forums
- Responsible for identifying and implementing process improvements using established methods (principles of lean and six sigma) in collaboration with experts
- Provide review and expert opinion in developing, revising, and maintaining standard core operating procedures and work instructions
- Perform other duties as directed by the DOC, DTL or Manager, or meet objectives as assigned
- Develop and maintain good communications and working relationships with the CDM team and client stakeholders
Qualifications and experience
- High School Diploma or equivalent Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent Pref
- 7 years relevant experience in clinical trials within a similar function, including proven competence in managing the delivery of coding or/and other data management processes for multiple global projects, also including experience in handling complex customer negotiations and bid defense meeting.
- 5 years thesaurus management experience is essential
- Excellent knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHODD, ICD9, etc.).
- Excellent knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology required for many tasks.
- Advanced knowledge of data management processes and systems and advanced ability to apply this knowledge in practice.
- Excellent understanding of clinical drug development process (detail oriented).
- Good project management skills related to all phases of clinical studies.
- Excellent knowledge of operating procedures and work instructions and the ability to apply them in practice.
- Excellent English written and oral communication skills.
go to method of application »
Job Overview
- Manage single and multi-service projects, ensuring quality deliverables on time, within budget and to the customer’s satisfaction; Provide expert skills as part of a Clinical Data Management (CDM) team to provide quality data that meet customer needs; Provide leadership to the team in the area of coding, project planning and execution, financial management, communication and milestone tracking; Viewed as an expert in coding of clinical data.
Essential Functions
- Serve as an account lead, or internal or external point of contact on standalone coding studies or accounts
- Maintain post-coding dictionary up-versioning synonym and coding reconciliation to align coding to latest dictionary versions.
- Perform Dictionary up-versioning activities.
- Perform external verbatim coding of data from non-EDC sources in line with required coding dictionary versions.
- Manage the customer relationship for the project team including active participation in coding related customer negotiation on timeline, budgetary and other issues
- Provide support to lead coders on one or more large global studies
- Manage the relationship with a customer
- Serve independently as a Lead Data Coder and/or Coding reviewer for one or more projects
- May serve as a DOC or DTL for one or more projects
- Perform comprehensive quality control procedures
- Perform Serious Adverse Event (SAE) coding reconciliation activities
- Collaborate with customers and develop solutions and action plans for issues, escalations and road blocks
- Proactively identify, solve quality issues and deliver projects as per agreed timeline
- Identify and provide due diligence for out of scope activity
- Manage resource capacity for the project team
- Mentor other team members in training and developing coding expertise
- Independently bring project solutions to the Coding and CDM team
- Identify and implement processes and quality improvement initiatives in the DM and coding function
- Developing and implementing best practices in the team
- Manage the development and implementation of new technologies
- Demonstrate scientific and research temperament by presenting at, or participating in local and international forums
- Responsible for identifying and implementing process improvements using established methods (principles of lean and six sigma) in collaboration with experts
- Provide review and expert opinion in developing, revising, and maintaining standard core operating procedures and work instructions
- Perform other duties as directed by the DOC, DTL or Manager, or meet objectives as assigned
- Develop and maintain good communications and working relationships with the CDM team and client stakeholders
Qualifications and experience
- High School Diploma or equivalent Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent Pref
- 7 years relevant experience in clinical trials within a similar function, including proven competence in managing the delivery of coding or/and other data management processes for multiple global projects, also including experience in handling complex customer negotiations and bid defense meeting.
- 5 years thesaurus management experience is essential
- Excellent knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHODD, ICD9, etc.).
- Excellent knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology required for many tasks.
- Advanced knowledge of data management processes and systems and advanced ability to apply this knowledge in practice.
- Excellent understanding of clinical drug development process (detail oriented).
- Good project management skills related to all phases of clinical studies.
- Excellent knowledge of operating procedures and work instructions and the ability to apply them in practice.
- Excellent English written and oral communication skills.
go to method of application »
Job Overview
- Manage single and multi-service projects, ensuring quality deliverables on time, within budget and to the customer’s satisfaction; Provide expert skills as part of a Clinical Data Management (CDM) team to provide quality data that meet customer needs; Provide leadership to the team in the area of coding, project planning and execution, financial management, communication and milestone tracking; Viewed as an expert in coding of clinical data.
Essential Functions
- Serve as an account lead, or internal or external point of contact on standalone coding studies or accounts
- Maintain post-coding dictionary up-versioning synonym and coding reconciliation to align coding to latest dictionary versions.
- Perform Dictionary up-versioning activities.
- Perform external verbatim coding of data from non-EDC sources in line with required coding dictionary versions.
- Manage the customer relationship for the project team including active participation in coding related customer negotiation on timeline, budgetary and other issues
- Provide support to lead coders on one or more large global studies
- Manage the relationship with a customer
- Serve independently as a Lead Data Coder and/or Coding reviewer for one or more projects
- May serve as a DOC or DTL for one or more projects
- Perform comprehensive quality control procedures
- Perform Serious Adverse Event (SAE) coding reconciliation activities
- Collaborate with customers and develop solutions and action plans for issues, escalations and road blocks
- Proactively identify, solve quality issues and deliver projects as per agreed timeline
- Identify and provide due diligence for out of scope activity
- Manage resource capacity for the project team
- Mentor other team members in training and developing coding expertise
- Independently bring project solutions to the Coding and CDM team
- Identify and implement processes and quality improvement initiatives in the DM and coding function
- Developing and implementing best practices in the team
- Manage the development and implementation of new technologies
- Demonstrate scientific and research temperament by presenting at, or participating in local and international forums
- Responsible for identifying and implementing process improvements using established methods (principles of lean and six sigma) in collaboration with experts
- Provide review and expert opinion in developing, revising, and maintaining standard core operating procedures and work instructions
- Perform other duties as directed by the DOC, DTL or Manager, or meet objectives as assigned
- Develop and maintain good communications and working relationships with the CDM team and client stakeholders
Qualifications and experience
- High School Diploma or equivalent Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent Pref
- 7 years relevant experience in clinical trials within a similar function, including proven competence in managing the delivery of coding or/and other data management processes for multiple global projects, also including experience in handling complex customer negotiations and bid defense meeting.
- 5 years thesaurus management experience is essential
- Excellent knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHODD, ICD9, etc.).
- Excellent knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology required for many tasks.
- Advanced knowledge of data management processes and systems and advanced ability to apply this knowledge in practice.
- Excellent understanding of clinical drug development process (detail oriented).
- Good project management skills related to all phases of clinical studies.
- Excellent knowledge of operating procedures and work instructions and the ability to apply them in practice.
- Excellent English written and oral communication skills.
go to method of application »
- As a Key Account Manager, you will promote, recommend, and sell solutions, products and services to your Key Account Portfolio. This includes developing, managing, and implementing sales strategies, identifying potential customers, and cultivating existing customer relationships to close deals.
- Our Key Account Managers work closely with our consulting services to coordinate the best solutions for our clients. Get client referrals and increasing amount or type of coverage for existing accounts; continuously liaise between internal teams and clients to ensure service delivery; and serve as a primary contact on an ongoing basis by addressing ad hoc client requests and managing client satisfaction.
Main Responsibilities
- Fosters sustainable and profitable partnerships with major clients by developing and maintaining multiple stakeholder relationships within each account.
- Leveraging IQVIA’s solutions to add value and identify new business opportunities and ultimately grow revenue.
Desired Qualifications and Experience
- Bachelor’s degree or similar required.
- Typically requires 5+ years of prior relevant pharmaceutical/healthcare industry experience, ideally in multiple roles such as Sales (required), Account Management (preferred), Sales Management, Product Management, Marketing (preferred), Sales Force Effectiveness and Business Operations/Analytics (preferred).
- Industry Knowledge – Thorough understanding of the nuances of the South African healthcare sector.
- Emotional Intelligence - Connect with and effectively manage all client and internal engagements.
- Problem Solving and Analytical – Basic analytical ability to assess challenges and provide solutions.
- Collaborative - Works well with others to proactively meet client needs and drive success.
- Action and Deadline Orientated - Operates with a sense of urgency in a deadline-orientated environment.
- Learnability - Strong ability to expand their knowledge base and continuously grow.
- Attention to Detail - Detail-orientated, but not at the cost of slowing down progress.
- Strong Communicator - Articulate an ability to effectively express themselves.
go to method of application »
- IQVIA is seeking experienced Clinical Data Management Leads to oversee end-to-end data management delivery for global clinical trials. You’ll ensure quality, accuracy, and compliance while leading cross-functional teams that help bring new therapies to life. This is a remote/WFH position with all necessary equipment provided.
What You’ll Do
- Lead data management for complex, global clinical trials from study setup to database lock.
- Serve as the main client contact for all data management deliverables.
- Oversee SAE, PK, and external data reconciliation and database deployment.
- Manage timelines, budgets, and resource allocation to meet customer expectations.
- Mentor junior data management staff and promote best practices.
- Drive process improvements and ensure regulatory and SOP compliance.
Who We’re Looking For
Ideal candidates will have....
- Bachelor’s degree in life sciences, health, clinical, biological, or mathematical field.
- No less than 10 years of direct clinical data management experience, with 5+ years in a Lead Clinical Data Management role.
- Your previous roles/job titles may include Clinical Data Manager, Senior Clinical Data Manager, Lead Data Manager, Principal Data Manager, and/or Data Management Project Manager.
- Proven success managing large global studies (1000+ patients).
- Expertise with Medidata Rave, Oracle InForm, or similar EDC systems.
- Strong understanding of GCP, ICH, and clinical research processes.
- Excellent communication and leadership skills.
go to method of application »
- IQVIA is seeking experienced Clinical Data Management Leads to oversee end-to-end data management delivery for global clinical trials. You’ll ensure quality, accuracy, and compliance while leading cross-functional teams that help bring new therapies to life. This is a remote/WFH position with all necessary equipment provided.
What You’ll Do
- Lead data management for complex, global clinical trials from study setup to database lock.
- Serve as the main client contact for all data management deliverables.
- Oversee SAE, PK, and external data reconciliation and database deployment.
- Manage timelines, budgets, and resource allocation to meet customer expectations.
- Mentor junior data management staff and promote best practices.
- Drive process improvements and ensure regulatory and SOP compliance.
Who We’re Looking For
Ideal candidates will have....
- Bachelor’s degree in life sciences, health, clinical, biological, or mathematical field.
- No less than 10 years of direct clinical data management experience, with 5+ years in a Lead Clinical Data Management role.
- Your previous roles/job titles may include Clinical Data Manager, Senior Clinical Data Manager, Lead Data Manager, Principal Data Manager, and/or Data Management Project Manager.
- Proven success managing large global studies (1000+ patients).
- Expertise with Medidata Rave, Oracle InForm, or similar EDC systems.
- Strong understanding of GCP, ICH, and clinical research processes.
- Excellent communication and leadership skills.
go to method of application »
- IQVIA is seeking experienced Clinical Data Management Leads to oversee end-to-end data management delivery for global clinical trials. You’ll ensure quality, accuracy, and compliance while leading cross-functional teams that help bring new therapies to life. This is a remote/WFH position with all necessary equipment provided.
What You’ll Do
- Lead data management for complex, global clinical trials from study setup to database lock.
- Serve as the main client contact for all data management deliverables.
- Oversee SAE, PK, and external data reconciliation and database deployment.
- Manage timelines, budgets, and resource allocation to meet customer expectations.
- Mentor junior data management staff and promote best practices.
- Drive process improvements and ensure regulatory and SOP compliance.
Who We’re Looking For
Ideal candidates will have....
- Bachelor’s degree in life sciences, health, clinical, biological, or mathematical field.
- No less than 10 years of direct clinical data management experience, with 5+ years in a Lead Clinical Data Management role.
- Your previous roles/job titles may include Clinical Data Manager, Senior Clinical Data Manager, Lead Data Manager, Principal Data Manager, and/or Data Management Project Manager.
- Proven success managing large global studies (1000+ patients).
- Expertise with Medidata Rave, Oracle InForm, or similar EDC systems.
- Strong understanding of GCP, ICH, and clinical research processes.
- Excellent communication and leadership skills.
Method of Application
Use the link(s) below to apply on company website.
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