Jobs at IQVIA

The Associate SAM is a fundamental role to deliver our clinical trial portfolio and belongs to a global unit with vast career growth opportunities.
Typical day to day includes working on 1-2 projects or a same client program performing the following activities:

• Participation of pre award and big defense meeting activities providing start up expertise input for the project strategy.
• Upon award, develop the site activation delivery strategy according to project scope and specifics, indicating the activation projection for sites in diverse countries, site identification, regulatory, contract and start up elements’ timelines.
• Oversee the execution of global site activation strategy, focusing in delivering sites in the agreed timeline, budget and within scope, pro-actively identifying and addressing risks.
• Communication with client, project team members and local regulatory specialists on study sites status, activation projections, risks, and opportunities to secure the activation strategy.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Must have a Bachelor's Degree Life sciences or related field.
• At least 3 years with 1 year of global experience in a clinical research environment.
• Strong leadership competencies to lead projects and multi-cultural teams.
• Project ownership controlling delivery on time, within scope and controlling budget.
• Demonstrable experience working on multiple projects or clients balancing competing priorities
• Strong communication skills with the ability to negotiated and challenge decisions
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects.
• Proven ability to establish and maintain effective working relationships with co-workers, managers, and sponsors.

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Job Overview

• The Global Study Associate is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management to time, cost and quality.
• The GSA supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving.
• The GSA supports the Global Study Director (GSD), Global Study Associate Director (GSAD) and/or Global Study Manager (GSM) with coordinating activities, ensuring quality and consistency.
• The GSA supports with administration & systems and with other delegated aspects of clinical study execution in accordance with applicable clinical trial regulations (ex. ICH-GCP).

Essential Functions

• Support GS(A)D and GSMs by completing delegated study work. May work across many different studies and delivery models concurrently.
• Initiate and lead the set-up of the electronic Trial Master File (eTMF). Maintain and close the eTMF to ensure compliance to International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and client's SOPs.
• Interact/collaborate with internal staff and external stakeholders in collection of regulatory and other essential documents.
• Contribute to electronic applications/submissions in ANGEL by creating and managing clinical regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. Proactively plan and collate the administrative appendices for the CSR.
• Initiate and maintain production of study documents, ensuring template and version compliance per study specific requirements.
• Set-up, populate and accurately maintain information in client's tracking and communication tools and support team members in the usage of these tools.
• Support the set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant stakeholders to fulfil client's compliance and meet the regulatory authority needs.
• Support the GS(A)D with tracking, reconciliation and follow-up of the study budget/payments in relevant systems.
• Contribute to application, coordination, supply and tracking of study materials and equipment. Contribute to collection of study supplies, if required, at the study close-out.
• Coordinate administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs.
• Prepare, contribute and distribute presentation material for meetings, newsletters and websites.

Qualifications

• Education in medical or biological sciences or discipline associated with clinical research preferred
• Proven organizational and analytical skills
• Previous administrative training/experience
• Excellent verbal and written communication in English
• Demonstrate ability to work independently, as well as in a team environment
• Ability to prepare presentation materials
• Demonstrate professionalism and mutual respect
• Willingness and ability to train others on study administration procedures
• Experience in clinical study lifecycle

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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.

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Job Overview

• Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster.
• The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices.
• Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. Clinical Project leads can run their own studies. The Project Lead focus is on leveraging therapeutic expertise and IQVIA’s suite of solutions to drive operational excellence and strategic leadership with our customers

Essential Functions

• Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.
• May be responsible for delivery and management of smaller, less complex, regional studies.
• Develop integrated study management plans with the core project team.
• Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
• Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally.
• Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
• May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as communicate/collaborate with IQVIA business development representatives, as necessary.;
• Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
• Ensure the financial success of the project.
• Forecast and identify opportunities to accelerate activities to bring revenue forward.
• Identify changes in scope and manage change control process as necessary.
• Identify lessons learned and implement best practices.
• May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.;
• Adopt corporate initiatives and changes and serve as a change advocate when necessary.
• Provide input to line managers of their project team members’ performance relative to project tasks.
• Support staff development and mentor less experienced project team members on assigned projects to support their professional development.;

Qualifications

• Bachelor's Degree Life sciences or related field
• 5 years of prior relevant experience including > 1 year of project management experience with a CRO.
• Advanced knowledge of job area, and broad knowledge of other related job areas, typically obtained through advanced education combined with experience.
• Knowledge of clinical trials - 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. Broad protocol knowledge; therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.;

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Job Overview

• The Global Study Manager is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clincal Operations, Study Management to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving.
• The GSM works cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with Global Study Director (GSD) or Global Study Associate Director (GSAD) in delegated aspects of clinical study execution in accordance with the Delivery Model.

Essential Functions

• In partnership with client's team,
• Leads/contributes to the preparation of delegated study documents (e.g., Informed Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc.).
• Maintains and facilitates interactions with internal functions and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives.
• Contributes to the planning and conduct of internal and external meetings (e.g., Investigators’/Monitors’ meeting).
• Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
• Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
• Ensures that all study documents in scope of GSM’s responsibilities are complete and verified for quality in Trial Master File.
• Supports GSD and/or GSAD with budget management, such as external service provider invoice reconciliation.
• Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times.
• Supports GSD and/or GSAD with overall project management as per agreed delegation.
• For outsourced studies, supports GSD and/or GSAD in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with
• Internal BioPharmaceuticals Clinical Operations Job Description
• relevant client's SOPs and guidelines (e.g., description of services and transfer of obligations)
• Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager

Qualifications

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
• Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
• Knowledge of clinical development / drug development process in various phases of development and therapy areas
• Excellent knowledge of international guidelines ICH/GCP
• Excellent communication and relationship building skills, including external service provider management skills
• Good project management skills
• Demonstrated ability to collaborate as well as work independently
• Demonstrated leadership skills
• Computer proficiency, advanced computer skills in day-to-day tasks
• Excellent verbal and written communication in English

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• This is an excellent opportunity to join a dynamic global business team responsible for developing budgets and proposals that support our Laboratory (IQVIA Laboratories) division.

The role offers a strong learning path and is ideal for someone who wants to grow into a world‑class business analyst. Strong communication skills and solid Excel knowledge are essential for success.

What You Will Do

As a Proposal Developer 1, you will support the global sales team by preparing high‑quality budgets, proposals, and related documentation.

Your key responsibilities include:

Proposal & Budget Development

• Review Requests for Proposal (RFPs) and extract all necessary information for proposal text and budget creation.
• Prepare proposal text, budgets, rebids, and supporting documents.
• Ensure all scopes of work are clear and that budgets accurately reflect project expectations.

Collaboration & Support

• Work closely with the proposal development team and assist other Proposal Developers when needed.
• Collaborate with cross‑functional internal stakeholders to develop and deliver high‑quality, compliant proposals.
• Join strategy calls to clarify customer requirements and identify inconsistencies in the provided information.

Quality, Compliance & Documentation

• Edit and review documents for quality and accuracy before final submission.
• Ensure all proposals follow relevant internal processes and compliance requirements.
• Update and maintain corporate databases and ensure all tracking reports contain accurate information.
• Participate in departmental initiatives and occasional customer meetings.

Additional Duties

• Support preliminary agreements and related scopes of work.
• Contribute to continuous improvement within the department.
• Perform other tasks as assigned.

What You Bring

To be successful in this role, you should have:

Education & Experience

• Bachelor’s degree in Life Sciences, Business Management, or a related field.
• Minimum of 1 year of experience in proposals, budgeting, or a similar role (or a combination of education and relevant experience).

Technical Skills

• Strong knowledge of Microsoft Excel and Word.
• Understanding of costing models and the ability to interpret RFPs and study protocols.
• Familiarity with the CRO (Clinical Research Organization) industry is a plus.

Soft Skills

• Excellent verbal and written communication skills.
• Strong analytical thinking and attention to detail.
• Ability to collaborate effectively with colleagues, managers, and customers.
• Strong organizational skills and the ability to manage multiple priorities.

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• This role is part of a sponsor dedicated project where you will be working with the client directly to manage deliveries.
• The CMA contributes to the execution of the Centralized Monitoring process by performing the setup, programming and refresh(es) of the Centralized Monitoring platform, according to the study-specific Centralized Monitoring Plan (CMP).

Main responsibilities include:

• Supports the Centralized Monitoring Lead (CML) in the development of the fit-for purpose CM strategy by contributing to the identification of the relevant CM elements to be implemented for the study (Quality Tolerance Limits (QTL), Key Risk Indicators, data visualizations and Data Quality Assessments)
• Setup/Program QTL, KRI and Data Quality Assessments according to the study CMP
• Refresh the Centralized Monitoring Platform at predefined frequency to enable signal identification
• Generate and maintain the Centralized Monitoring Platform specifications document and file it in eTMF
• Review and understanding of protocol is key
• Understand the data sources for the study, the data transfer specifications and the data structure
• Execute and document peer-review of CM platform setup done by other CMA colleagues

Experience:

• At least 3 years relevant experience in the area of pharmaceutical research and development or related field preferably in centralized Monitoring, data management, and/or biostatistics
• 2-3 years SAS experience including macro language
• Knowledge/ experience working on Cluepoints
• Ability to work in an autonomous way and engage with relevant stakeholders to execute activities related to study level centralized monitoring process.
• Ability to understand basic statistical analysis concepts and to interpret their outcome.
• Ability to maintain confidentiality of data and information during interactions with staff at all levels
• Ability to work with limited close supervision.
• Demonstrated communication, interpersonal, organizational and problem-solving skills
• High levels of initiative, drive and commitment.
• Prior experience in a Data Management related field is required
• Experience with relational databases, preferably Clinical Data Management and EDC Systems
• Experience communicating with all levels of personnel and participating in collaborative work team (locally and globally).
• Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.
• Excellent command, both verbal and written, of English

go to method of application »

• This role is part of a sponsor dedicated project where you will be working with the client directly to manage deliveries.
• The CMA contributes to the execution of the Centralized Monitoring process by performing the setup, programming and refresh(es) of the Centralized Monitoring platform, according to the study-specific Centralized Monitoring Plan (CMP).

Main responsibilities include:

• Supports the Centralized Monitoring Lead (CML) in the development of the fit-for purpose CM strategy by contributing to the identification of the relevant CM elements to be implemented for the study (Quality Tolerance Limits (QTL), Key Risk Indicators, data visualizations and Data Quality Assessments)
• Setup/Program QTL, KRI and Data Quality Assessments according to the study CMP
• Refresh the Centralized Monitoring Platform at predefined frequency to enable signal identification
• Generate and maintain the Centralized Monitoring Platform specifications document and file it in eTMF
• Review and understanding of protocol is key
• Understand the data sources for the study, the data transfer specifications and the data structure
• Execute and document peer-review of CM platform setup done by other CMA colleagues

Experience:

• At least 3 years relevant experience in the area of pharmaceutical research and development or related field preferably in centralized Monitoring, data management, and/or biostatistics
• 2-3 years SAS experience including macro language
• Knowledge/ experience working on Cluepoints
• Ability to work in an autonomous way and engage with relevant stakeholders to execute activities related to study level centralized monitoring process.
• Ability to understand basic statistical analysis concepts and to interpret their outcome.
• Ability to maintain confidentiality of data and information during interactions with staff at all levels
• Ability to work with limited close supervision.
• Demonstrated communication, interpersonal, organizational and problem-solving skills
• High levels of initiative, drive and commitment.
• Prior experience in a Data Management related field is required
• Experience with relational databases, preferably Clinical Data Management and EDC Systems
• Experience communicating with all levels of personnel and participating in collaborative work team (locally and globally).
• Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.
• Excellent command, both verbal and written, of English

go to method of application »

Job Overview

• Our ever-growing Lifecycle Safety Medical team is expanding. We are hiring Pharmacovigilance Scientist (Safety Aggregate Report Specialist) in Serbia, Croatia, Portugal, Hungary, Slovakia, Romania, Bulgaria, Greece and South Africa. As principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements.

Essential Functions

• Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects.
• Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings
• Author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
• Act as literature lead, back-up lead, reviewer/QCers to contribute in the conduct of ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines.
• Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. Conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks. Participate as core member and present in safety management teams. Responsible for full documentation and tracking of signals.
• In a PV support role, author safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
• Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.
• Participate in internal and external audits and inspections, as required.
• Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
• Read,acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion to maintain compliance and documented.
• Serve as the interface between the global project lead and the working team
• conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
• Provide mentorship and training to less experienced resources.
• Provide regular reports to overall project manager and department management on project metrics, statement of work (SOW) changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner.
• Support and/or contribute to technology / innovation activities.

Qualifications

• Bachelor's Degree In a Scientific or Healthcare discipline, or Equivalent combination of education, training and experience
• 1 - 2 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management, or literature surveillance.
• Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role.
• Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, PowerPoint).
• Good knowledge of medical terminology.
• Strong organizational skills and time management skills, excellent attention to detail and accuracy.
• Strong verbal/written communication skills.
• Self-motivated and flexible.
• Ability to follow instructions/guidelines, utilize initiative and work independently.
• Proven ability to multi-task, manage competing priorities and deadlines.
• Willingness and aptitude to learn new skills across all Lifecycle Safety service lines.

go to method of application »

Job Overview

• Our ever-growing Lifecycle Safety Medical team is expanding. We are hiring Pharmacovigilance Scientist (Safety Aggregate Report Specialist) in Serbia, Croatia, Portugal, Hungary, Slovakia, Romania, Bulgaria, Greece and South Africa. As principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements.

Essential Functions

• Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects.
• Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings
• Author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
• Act as literature lead, back-up lead, reviewer/QCers to contribute in the conduct of ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines.
• Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. Conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks. Participate as core member and present in safety management teams. Responsible for full documentation and tracking of signals.
• In a PV support role, author safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
• Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.
• Participate in internal and external audits and inspections, as required.
• Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
• Read,acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion to maintain compliance and documented.
• Serve as the interface between the global project lead and the working team
• conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
• Provide mentorship and training to less experienced resources.
• Provide regular reports to overall project manager and department management on project metrics, statement of work (SOW) changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner.
• Support and/or contribute to technology / innovation activities.

Qualifications

• Bachelor's Degree In a Scientific or Healthcare discipline, or Equivalent combination of education, training and experience
• 1 - 2 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management, or literature surveillance.
• Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role.
• Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, PowerPoint).
• Good knowledge of medical terminology.
• Strong organizational skills and time management skills, excellent attention to detail and accuracy.
• Strong verbal/written communication skills.
• Self-motivated and flexible.
• Ability to follow instructions/guidelines, utilize initiative and work independently.
• Proven ability to multi-task, manage competing priorities and deadlines.
• Willingness and aptitude to learn new skills across all Lifecycle Safety service lines.

go to method of application »

Job Overview

• Our ever-growing Lifecycle Safety Medical team is expanding. We are hiring Pharmacovigilance Scientist (Safety Aggregate Report Specialist) in Serbia, Croatia, Portugal, Hungary, Slovakia, Romania, Bulgaria, Greece and South Africa. As principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements.

Essential Functions

• Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects.
• Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings
• Author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
• Act as literature lead, back-up lead, reviewer/QCers to contribute in the conduct of ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines.
• Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. Conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks. Participate as core member and present in safety management teams. Responsible for full documentation and tracking of signals.
• In a PV support role, author safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
• Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.
• Participate in internal and external audits and inspections, as required.
• Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
• Read,acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion to maintain compliance and documented.
• Serve as the interface between the global project lead and the working team
• conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
• Provide mentorship and training to less experienced resources.
• Provide regular reports to overall project manager and department management on project metrics, statement of work (SOW) changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner.
• Support and/or contribute to technology / innovation activities.

Qualifications

• Bachelor's Degree In a Scientific or Healthcare discipline, or Equivalent combination of education, training and experience
• 1 - 2 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management, or literature surveillance.
• Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role.
• Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, PowerPoint).
• Good knowledge of medical terminology.
• Strong organizational skills and time management skills, excellent attention to detail and accuracy.
• Strong verbal/written communication skills.
• Self-motivated and flexible.
• Ability to follow instructions/guidelines, utilize initiative and work independently.
• Proven ability to multi-task, manage competing priorities and deadlines.
• Willingness and aptitude to learn new skills across all Lifecycle Safety service lines.

go to method of application »

• Our ever-growing Lifecycle Safety Medical team is expanding. We are hiring Pharmacovigilance Scientist 2 (Safety Aggregate Report Specialist 2) in Serbia, Croatia, Portugal, Hungary, Slovakia, Romania, Bulgaria, Greece and South Africa.
• Serving as an expert for Safety Aggregate Report and Analytics (SARA) Center deliverables, including safety aggregate reports, literature surveillance, signal management activities, and benefit–risk management documentation.

Essential Functions

• Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).
• Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings
• Author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
• Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
• Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals.
• In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
• Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.
• Participate in internal and external audits and inspections, as required.
• Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
• Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
• Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
• Provide mentorship and training to less experienced resources.
• Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP).
• Support and/or contribute to technology / innovation activities.

Qualifications

• Bachelor's Degree In a Scientific or Healthcare discipline, or Equivalent combination of education, training and experience
• 2 - 3 years relevant work experience.
• Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines.
• In depth knowledge and understanding of applicable global, regional, local regulatory requirements. i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs.
• Manage competing priorities and ability to be flexible and receptive to changing demands, and proven ability to meet strict deadlines.
• Excellent organizational skills and time management skills.
• Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, PowerPoint).
• Good knowledge of medical terminology.
• Proven ability to follow instructions/guidelines, work independently and on own initiative.
• Excellent attention to detail and accuracy maintaining consistently high quality standards.
• Excellent written/verbal communication and report writing skills.
• Independent thinking and decision making skills; sound judgement.
• Self-motivated and flexible.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Effective mentoring and coaching skills.
• Good understanding of operational metrics, productivity and initiatives.
• Demonstrate effective project management and leadership skills.

go to method of application »

• Our ever-growing Lifecycle Safety Medical team is expanding. We are hiring Pharmacovigilance Scientist 2 (Safety Aggregate Report Specialist 2) in Serbia, Croatia, Portugal, Hungary, Slovakia, Romania, Bulgaria, Greece and South Africa.
• Serving as an expert for Safety Aggregate Report and Analytics (SARA) Center deliverables, including safety aggregate reports, literature surveillance, signal management activities, and benefit–risk management documentation.

Essential Functions

• Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).
• Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings
• Author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
• Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
• Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals.
• In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
• Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.
• Participate in internal and external audits and inspections, as required.
• Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
• Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
• Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
• Provide mentorship and training to less experienced resources.
• Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP).
• Support and/or contribute to technology / innovation activities.

Qualifications

• Bachelor's Degree In a Scientific or Healthcare discipline, or Equivalent combination of education, training and experience
• 2 - 3 years relevant work experience.
• Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines.
• In depth knowledge and understanding of applicable global, regional, local regulatory requirements. i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs.
• Manage competing priorities and ability to be flexible and receptive to changing demands, and proven ability to meet strict deadlines.
• Excellent organizational skills and time management skills.
• Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, PowerPoint).
• Good knowledge of medical terminology.
• Proven ability to follow instructions/guidelines, work independently and on own initiative.
• Excellent attention to detail and accuracy maintaining consistently high quality standards.
• Excellent written/verbal communication and report writing skills.
• Independent thinking and decision making skills; sound judgement.
• Self-motivated and flexible.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Effective mentoring and coaching skills.
• Good understanding of operational metrics, productivity and initiatives.
• Demonstrate effective project management and leadership skills.

go to method of application »

• Our ever-growing Lifecycle Safety Medical team is expanding. We are hiring Pharmacovigilance Scientist 2 (Safety Aggregate Report Specialist 2) in Serbia, Croatia, Portugal, Hungary, Slovakia, Romania, Bulgaria, Greece and South Africa.
• Serving as an expert for Safety Aggregate Report and Analytics (SARA) Center deliverables, including safety aggregate reports, literature surveillance, signal management activities, and benefit–risk management documentation.

Essential Functions

• Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).
• Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings
• Author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
• Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
• Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals.
• In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
• Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.
• Participate in internal and external audits and inspections, as required.
• Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
• Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
• Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
• Provide mentorship and training to less experienced resources.
• Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP).
• Support and/or contribute to technology / innovation activities.

Qualifications

• Bachelor's Degree In a Scientific or Healthcare discipline, or Equivalent combination of education, training and experience
• 2 - 3 years relevant work experience.
• Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines.
• In depth knowledge and understanding of applicable global, regional, local regulatory requirements. i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs.
• Manage competing priorities and ability to be flexible and receptive to changing demands, and proven ability to meet strict deadlines.
• Excellent organizational skills and time management skills.
• Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, PowerPoint).
• Good knowledge of medical terminology.
• Proven ability to follow instructions/guidelines, work independently and on own initiative.
• Excellent attention to detail and accuracy maintaining consistently high quality standards.
• Excellent written/verbal communication and report writing skills.
• Independent thinking and decision making skills; sound judgement.
• Self-motivated and flexible.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Effective mentoring and coaching skills.
• Good understanding of operational metrics, productivity and initiatives.
• Demonstrate effective project management and leadership skills.

go to method of application »

• Review and provide input into all trial set-up documentation
• Translate protocol and any applicable de-risking into the creation and maintenance of detailed technical specifications, mapping documentation including aCRF, data transfer agreements, as applicable, etc.
• Creation of Data Review Model (DRM) based on current Client standards and SDTM datasets based on current SDTM standards
• Creation of back-end edit checks, listings, and visualizations to support risk-based central monitoring, e.g., Quality Tolerance Limits (QTLs), Critical to Quality (CtQ), etc., and ongoing clinical and safety data review
• QC of all clinical programming deliverables
• Perform unblinding, data-cut activities for planned reporting milestones and database locks
• Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA, and other regulatory agencies as needed.
• Support the development of standards and drive implementation within the organization

Experience

• Minimum 4+ years of relevant experience in SDTM Clinical Programming
• Good knowledge of data structures and relevant programming languages for data manipulation and reporting (i.e., SAS, SQL, Python, R, etc.)
• Strong knowledge of complex finding data types, including but not limited to biomarkers, and digital data such as ECG, imaging, etc.
• Advanced knowledge of SDTM including Define.xml, CDASH, and metadata as well as experience transforming transferred vendor data into SDTM preferred, knowledge of ADaM a plus
• Demonstrated understanding of current industry standards for submission of clinical trial data.
• Demonstrated organizational and leadership skills to handle multiple competing priorities simultaneously across projects.
• Ability to communicate with cross-functional teams, and business partners and gather feedback for study specifications and/or data issues.

go to method of application »

• Review and provide input into all trial set-up documentation
• Translate protocol and any applicable de-risking into the creation and maintenance of detailed technical specifications, mapping documentation including aCRF, data transfer agreements, as applicable, etc.
• Creation of Data Review Model (DRM) based on current Client standards and SDTM datasets based on current SDTM standards
• Creation of back-end edit checks, listings, and visualizations to support risk-based central monitoring, e.g., Quality Tolerance Limits (QTLs), Critical to Quality (CtQ), etc., and ongoing clinical and safety data review
• QC of all clinical programming deliverables
• Perform unblinding, data-cut activities for planned reporting milestones and database locks
• Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA, and other regulatory agencies as needed.
• Support the development of standards and drive implementation within the organization

Experience

• Minimum 4+ years of relevant experience in SDTM Clinical Programming
• Good knowledge of data structures and relevant programming languages for data manipulation and reporting (i.e., SAS, SQL, Python, R, etc.)
• Strong knowledge of complex finding data types, including but not limited to biomarkers, and digital data such as ECG, imaging, etc.
• Advanced knowledge of SDTM including Define.xml, CDASH, and metadata as well as experience transforming transferred vendor data into SDTM preferred, knowledge of ADaM a plus
• Demonstrated understanding of current industry standards for submission of clinical trial data.
• Demonstrated organizational and leadership skills to handle multiple competing priorities simultaneously across projects.
• Ability to communicate with cross-functional teams, and business partners and gather feedback for study specifications and/or data issues.

go to method of application »

Job Overview

• The Senior Clinical Research Associate I (Sr CRA I) is responsible for monitoring and site management activities for asthma and respiratory clinical trials to ensure study conduct, subject safety, and data quality in compliance with study protocols, Good Clinical Practice (GCP), applicable regulations, and sponsor requirements.

Key Responsibilities

• Perform on-site monitoring visits (site selection, initiation, routine monitoring, and close-out) for asthma studies in accordance with GCP and contracted scope of work.
• Support investigative sites in executing asthma-specific recruitment strategies, including identification of eligible subjects based on disease severity, lung function criteria, and exacerbation history.
• Deliver protocol, asthma disease, and study-specific training, including procedures related to spirometry, FeNO, ePRO/eDiary use, and inhaler technique assessments.
• Review and assess site compliance with protocol requirements, including eligibility criteria, rescue and maintenance medication use, exacerbation management, and safety reporting.
• Monitor data quality and integrity for asthma endpoints such as lung function assessments, symptom scores, diary compliance, and adverse event reporting; escalate quality issues as needed.
• Track study progress, including regulatory submissions, enrollment, CRF completion, and query resolution; may support study start-up activities.
• Ensure essential documents are complete and filed accurately in the Trial Master File (TMF) and Investigator Site File (ISF) in accordance with GCP and local regulatory requirements.
• Prepare and maintain monitoring documentation, including visit reports, follow-up letters, and action plans related to site performance.
• Collaborate closely with cross-functional study team members (e.g., Clinical Operations, Data Management, Medical) to support successful trial execution.
• May support site-level recruitment planning and site financial management, including invoice review, as applicable.

Qualifications and Skills

• Bachelor’s degree in a scientific or healthcare-related discipline.
• Minimum of 3 years of on-site clinical trial monitoring experience, preferably within respiratory or asthma studies.
• Strong working knowledge of GCP, ICH guidelines, and applicable clinical research regulatory requirements.
• Familiarity with asthma clinical trial procedures, endpoints, and safety considerations is preferred.
• Proficiency in Microsoft Office and clinical trial systems; comfortable using mobile technology.
• Strong written and verbal communication skills with a good command of English.
• Excellent organizational, problem-solving, and time management skills.
• Ability to build and maintain effective working relationships with sites, colleagues, managers, and clients.

go to method of application »

• 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

go to method of application »

• 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