Fresh Openings at IQVIA

• This Clinical Data Team Lead will be responsible for managing end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Direct the team in areas of project planning, execution and close-out, financial management, communications and milestone deliverables. Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

Responsibilities

Client Management

• Serve as primary point of contact for customer on clinical data management deliverables
• Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
• Provide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resource
• Maintain strong customer relationships
• Ensure open communications with customer and Quintiles management to manage and meet contractual obligations

Service Management

• Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
• Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
• Support DM service delivery with comprehensive DM process and technical expertise in executing projects
• Serve as the escalation point for unresolved data issues; work with client data managers, vendors, and internal team members for resolution
• Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables
• Create and/or review and sign-off on all data management plan (DMP) documents
• Implement proactive quality management plans across multiple projects/programme. Track service performance and provide leadership to identify root causes of issues and implement remedial actions
• Serve as Subject Matter Expert (SME)
• Provide leadership and expertise in a specific CDM task or technology
• Maintain internal tracking databases and systems

Qualifications

• Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
• 5+ years direct Clinical Data Management experience in CRO or pharmaceuticals industry , including 3+ years as a CDM project lead; or equivalent combination of education, training and experience
• Previous experience and proven competence in managing delivery of multiple projects through full DM life-cycle (several studies/programmes)
• Previous experience of handling customer negotiations
• Knowledge of Good Clinical Practices and relevant regulatory guidelines
• Excellent communication, interpersonal, customer service, and teamwork skills
• Comprehensive understanding of clinical drug development process
• Ability to establish and maintain effective working relationships with co-workers, managers and customers
   

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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.

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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.