9 Clinical Data Management Resource Coordinator Homebased Europe jobs in Reading

Our team is growing, join us on our mission to drive healthcare forward!
What We Offer / USPs
+ The chance to work on cutting edge medicines at the forefront of new medicines development
+ IQVIA has access to significant data pools allowing better site selection and recruitment. This helps drive performance of sites making the CRA role more efficient and discussions at site more productive. Next generation clinical development!
+ We offer genuine career development opportunities for those who want to grow as part of the organization
+ We invest in keeping our teams stable, so workload is consistent
+ As a CRA you will receive an iPad and use of key developments such as site visit app's, site visit report app's that allow CRA's to do their day job more efficiently
Responsibilities
+ Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
+ Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
+ Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
+ Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
+ Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase
+ Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
+ Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
+ Collaborate and liaise with study team members for project execution support as appropriate
+ If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis
+ If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement
Requirements
+ You should be life science degree educated
+ You have experience of independent on-site monitoring experience
+ You've handled multiple protocols and sites across a variety of drug indications
+ Flexibility and ability to travel
+ Strong communication, written and presentation skills
*** This role is not eligible for UK Visa Sponsorship**
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled

Join Us on Our Mission to Drive Healthcare Forward
IQVIA cFSP (sponsor-dedicated) are seeking experienced Clinical Research Associates in the UK.
Why IQVIA?
+ IQVIA is recognized as #1 in its category on the 2025 Fortune® World's Most Admired Companies list for the FOURTH consecutive year!
+ We offer genuine career development opportunities for those who want to grow as part of the organization.
+ The chance to work on cutting edge medicines at the forefront of new medicines development.
+ IQVIA has access to significant data pools allowing better site selection and recruitment. This helps drive performance of sites making the CRA role more efficient and discussions at site more productive. Next generation clinical development!
Responsibilities
+ Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
+ Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
+ Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
+ Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
+ Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase
+ Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
+ Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
+ Collaborate and liaise with study team members for project execution support as appropriate
Requirements
+ Experience of independent on-site monitoring
+ You have successfully managed multiple clinical trial protocols across diverse investigative sites.
+ In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
+ Life science degree educated or equivalent industry experience
+ Flexibility to travel to sites
Apply today and forge a career with greater purpose, make an impact, and never stop learning!
#LI-ADAMTHOMPSON
*Please note - this role is not eligible for UK visa sponsorship*
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled

• Title: Associate Director, Clinical Research
• Contract: ASAP until 29-May-2026
• Location: Weybridge Hybrid – approx. 2 days on site

SRG are working with a world-leading consumer company who are seeking an Associate Director, Clinical Research to join the team.

Job Overview

Responsible for leading clinical research activities with a focus on clinical efficacy, effectiveness (through prospective Real World Evidence studies) and other clinical evidence generation activities by ensuring that high quality clinical research expertise is provided to meet state-of-the-art scientific, industry and regulatory standards (as needed).

Lead clinical development evidence generation activities in line with specific category/ sub-category project strategies.

Responsible for the development, this role will provide support to cross-functional category/ sub-category / Business Unit teams on clinical research, new opportunities/business development and R&D strategies. The role will require significant interaction with several internal teams including but not limited to Category and Business Unit Medical Affairs, Clinical Operations, Biostatistics & Data Management as well as external groups/ individuals such as investigators/ academic researchers, Clinical Research Organizations and Health Care Practitioners to help achieve company objectives and to build company reputation.

Key Responsibilities

• Provide appropriate scientific/technical contribution or author the clinical development plan for the studies/projects assigned.
• With support from the Clinical Research Director, design fit-for-purpose clinical strategies and other clinical evidence generation strategies to support the business for innovation product/therapy area including medical devices, in line with ICH GCP and other regulatory requirements (as needed).
• Support peer review publications/input to clinical section of regulatory dossiers to ensure that they are scientifically robust from a medical and scientific standpoint.
• Responsible for the design, implementation, reporting, interpretation, disclosure and publication of company sponsored clinical studies to ensure these follow external e.g. GCP, internal Medical Governance and other internal policy requirements.
• Responsible for contributing clinical content to regulatory submissions and other regulatory engagements for clinical research activities.
• Responsible for supporting clinical/medical due diligence for external opportunities from a clinical research point of view.

Knowledge/ Education / Previous Experience Required

• Advanced Scientific degree e.g. M.S. or MSc in Clinical Science or Medical/Dental or related discipline
• Minimum 8 years’ experience in clinical research/drug development in the Pharmaceutical/CRO or Healthcare industry, preferably in a Consumer Healthcare / FMCH / Pharmaceutical business Consumer Health care experience is greatly preferred.
• Previous experience within Oral Health, Wellness, Pain relief or Respiratory is an advantage.
• Proven ability to effectively liaise and influence internally and externally
• Ability to work in a multi-functional team
• Excellent verbal and written communication skills
• Excellent scientific writing skills
• Demonstrated experience and proven track record of delivering clinical development programs/clinical studies/clinical evidence gathering activities
• Demonstrated experience representing an organization with external stakeholders
• Demonstrated competent business acumen
• Excellent verbal and written communication skills in English
• Strong computer literacy including competency in Microsoft Office software

**Job Description Summary**
This role is to provide in house (limited travel) support relating to study set-up, monitoring and close-out activities to ensure the compliant and efficient conduct of GE HealthCare clinical studies.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
**Job Description**
**Responsibilities**
+ Perform initial contact and participate in the assessment and selection of qualified investigators for inclusion in clinical programs.
+ Serve as the primary in-house contact for sites and investigators participating in studies.
+ Work with on-site monitors, to ensure compliant and efficient study conduct at site.
+ Support the conduct of Pre-Selection (feasibility), Initiation, Monitoring, and Closeout site visits. Attending (co-monitoring) as required (minimal travel expected for this in house role).
+ Support with reviews of monitoring visit reports as required.
+ Provide input to the preparation of study documentation such as protocols, amendments, Case Report Forms, and study reports.
+ Facilitate and support the preparation of regulatory and IEC/IRB submissions
+ Facilitate the collection and processing (upload to eTMF) of essential documents and correspondence.
+ Ensure that the files for the site (TMF and working files) for which the job holder is responsible are up to date, accurate and include all essential documents as detailed in ICH-GCP.
+ Assist in the conduct of internal and external Trial Master File Audits, in accordance with applicable SOPs and regulations/guidelines.
+ Negotiate and track site/trial budget according to financial agreement with each site and facilitation of site contract execution.
+ Develop and/or review Patient information and Informed Consent Forms and other patient facing materials as required.
+ Assist with the tracking of subject enrollment at each trial site, and provide management with detailed reports of clinical activities, as requested.
+ Ensure that clinical sites have adequate supplies (IMP and Non-IMP) to perform the study.
+ Actively attend study team meetings, including follow-up on assigned action items.
+ Develop a thorough knowledge of the diagnostic/therapeutic field and clinical programme(s) for the studie(s) to which the job holder is assigned.
+ Support oversight of vendor(s), e.g. Central Laboratory, as needed.
+ Participate in the development and review of Standard Operating Procedures, guidelines, forms and checklists.
+ Assist in the coordination of investigator meetings.
+ Perform training to site personnel, vendor and internal study personnel, as required.
+ Actively identify and communicate areas for improvement within the global clinical research infrastructure at GE HealthCare
**Qualifications**
+ PhD, MSc or BSc in a scientific / medical discipline with at least 3 years Clinical Research (preferably monitoring) or equivalent experience
+ Thorough understanding of the processes that are part of the day-to-day work of Clinical Research
+ Demonstrable team-work, communication, interpersonal, and problem-solving skills
+ A good understanding of the relevant Regulatory Authority regulations, guidance and the drug development process
+ The ability to manage multiple priorities and work well under pressure and time constraints
+ Strong process improvement mindset, passion for quality.
+ Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).
+ Strong organizational skills with high attention to detail.
+ Familiarity with industry standard computerised system applications (e.g. eTMF, EDC, CTMS)
+ Experience with Veeva or other document/information management systems desired
+ Ability to work independently
**Inclusion and Diversity**
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
**Behaviours**
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
**Total Rewards**
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.
#LI-MG1
#LI-HYBRID
**Additional Information**
**Relocation Assistance Provided:** No

**Job Description Summary**
The Clinical Research Project Manager (Research Program Integrator - RPI) is responsible for leading and managing defined research activities for the Advanced Visualization Solutions (AVS) business within GE HealthCare. This role oversees cross-functional planning, execution, and communication to ensure timely, high-quality, and compliant delivery of research projects. The RPI manages the full lifecycle of research initiatives-from strategic planning through execution and closure-while meeting all quality, content, schedule, and budget targets.
**Job Description**
**Responsibilities**
**Project Execution**
- Manage internal and external research activities, including GEHC- and Investigator-Sponsored Studies, product evaluations, reader studies, and other strategic research initiatives.
- Lead cross-functional teams to execute research projects in alignment with business needs and study plans.
- Partner with the Research Manager (RM) to prioritize and adjust study details as needed.
**Compliance & Documentation**
- Ensure all research activities comply with cross-functional standards, Phased Review Discipline, QMS, SOPs, GCP, and applicable regional regulatory requirements.
- Develop and manage essential research documents, including protocols, study plans, informed consent forms, and document storage.
- Maintain accurate and timely study records in systems such as Clinical Trials Management System, MyWorkshop, ClinicalTrials.gov, Support Central, and others.
**Stakeholder & Site Management**
- Negotiate budgets and contracts with external partners and manage payment processes.
- Conduct or coordinate training, site initiation, monitoring, and study closure activities.
- Serve as a quality control reviewer for peer studies, supporting review and approval of study activities.
- Build and maintain professional, productive relationships with external research partners and study sites.
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
**Behaviors**
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
**Total Rewards**
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
**Additional Information**
**Relocation Assistance Provided:** No

**PURPOSE**
Establish and lead a Data Management Support Office framework to drive quality, consistency and efficiencies across a DM FSP model at IQVIA. Where applicable, performs and oversees data management activities in order to provide high quality data that meets client/project needs. Ensures that data is processed and tracked in alignment with regulatory and quality standards.
**RESPONSIBILITIES**
+ Liaise with customer counterpart and internal LT to understand Data Management Support Office business requirements. Develop and execute plan to meet these requirements.
+ Provides direction and support to Data Management Support Office leads in each of the following areas:
+ Onboarding and Training - partnering with customer Learning team to manage and deliver customer onboarding materials, DM role-based curricula/compliance, Train the Trainer etc.
+ Lead Support Office - establish structures to embed customer process/system/standards knowledge and support the institution of new customer lead roles at IQVIA.
+ Continuous Process Improvement - assess impact of customer process changes/establish structure for managing new ideas/process issues with customer.
+ Demand and capacity management.
+ Quality - managing QI investigations and CAPAs; eTMF Compliance.
+ KPI Reporting and Management
+ Provide strategic direction in the Data Management area.
+ Consolidate resource requirements and define staffing needs that ensure project objectives can be met while maximizing utilization, realization and minimizing costs.
+ Monitor and manage utilization and productivity. Ensure performance of staff is regularly assessed and documented. Define staffing needs based on hard backlog and strategic plan for office.
+ Define and implement department objectives consistent with broader office and regional objectives. Provide technical advice and solutions to solve problems and improve efficiency across functions, projects and customers.
+ Monitor quality and efficiency across projects to identify trends and opportunities for improvements. Ensure sharing of learning across projects and departments.
+ Participate in defining strategies for new processes and technology at either regional or global level. Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work.
+ Work with peers within office and regions to define and implement training strategies. Mentor staff members to develop Data Management, drug development and business expertise.
+ Manage relationship with customer functional peers. Provide operational input into proposals for large programs and strategic partnerships. Provide input to costing algorithms and standard proposal text.
+ Attend customer meetings and lead discussions of project requirements and strategic planning. Recommend placement of projects based on staffing levels and hard backlog, technology requirements and customer relationships. Ensure compliance of work with project's scope of work.
+ Actively assess and manage project realization. Ensure project milestones are met according to agree upon timelines with high quality. May serve as a Data Management Customer Liaison for one or more customers. Manage staff in accordance with organization's policies and applicable regulations.
+ Responsibilities include planning, assigning, and directing work, appraising performance, and guiding professional development rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.
+ May manage a Data Management Department, which could be either all data management staff at an office or a subset of staff (80-120) within a large Data Management office.
**REQUIRED KNOWLEDGE, SKILLS AND ABILITIES**
+ Advanced knowledge of Data Management processes and systems, including new technologies
+ Solid understanding of clinical drug development process and production of DM deliverables
+ Strategic leadership ability
+ Knowledge of business processes
+ Strong business acumen; financial management and budgeting skills.
+ Proven ability to work on multiple projects and manage competing priorities
+ Proven staff management skills, strong leadership, motivational and influencing skills.
+ Outstanding written and oral communication skills
+ Proven leadership skills
+ Outstanding problem-solving skills
+ Excellent interpersonal skills
+ Excellent organizational skills and demonstrated ability to delegate appropriately and monitor quality of outputs
+ Outstanding negotiation, decision-making and problem-solving skills.
+ Ability to establish and maintain effective working relationships with co-workers, managers and clients.
**MINIMUM REQUIRED EDUCATION AND EXPERIENCE**
- Bachelor's degree, or educational equivalence, in clinical, biological or mathematical sciences or related field, or nursing
qualification with 12 years of relevant work experience including substantial people management experience; or
equivalent combination of education, training and experience
**PHYSICIAL REQUIREMENTS**
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled

**PURPOSE**
Establish a Lead Support Office framework to embed customer process/system/standards knowledge and support the institution of new customer lead roles at IQVIA for a large DM FSP. Where applicable, performs and oversees data management activities in order to provide high quality data that meets client/project needs. Ensures that data is processed and tracked in alignment with regulatory and quality standards.
**RESPONSIBILITIES**
+ Establish knowledge management structures to embed the knowledge of customer process/systems/standards with IQVIA leads
+ Implementation of new customer lead roles, managing scope/RACI definition for optimal efficiency E2E
+ Liaise with PSS and Ops on the implementation of customer lead roles in PSS and Ops
+ Establish and maintain structures for mentoring and coaching, focusing on development and effectiveness of customer lead roles
+ Manage SME network, including responsibility for SME development and effectiveness
+ Establish and lead Knowledge Management Forums, lessons learned, CAPAs and best practices
+ Works with customer to develops tools and guidance to navigate and find information in customer process/systems/standards
+ Ensure IQVIA leads are aware of the support structure and ensure used effectively for consistency of approach
+ Ensure IQVIA leads are aware and adapt to process change and growth
+ Change Management Liaison
+ Participate in defining strategies for new processes and technology at either FSP or global level.
+ May manage a Functional Department of Data Management staff. Size of team could vary from 15-40 and may be a first-line or second-line management position.
+ Define and prioritize resource requirements and manage resource assignments across projects.
+ Monitor and manage utilization and productivity of Functional Department.
+ Assess and document competency of staff to satisfy position responsibilities. Regularly set goals and evaluates and documents performance.
+ Define recruiting strategies and staffing needs based on hard backlog.
+ Define and implement department objectives consistent with broader office company objectives.
+ Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF (case report form), database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers.
+ Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency.
+ Monitor quality and efficiency across projects to identify trends and opportunities for improvements. Ensure sharing of learning across projects.
+ Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work.
+ Define and implement training/professional development strategy for Functional Department.
+ Mentor staff members to develop Data Management process, system, and drug development expertise.
+ Manage relationship with customer at both the project team level and with functional peers.
+ Provide operational input into proposals and scope of work. Participate in proposal defenses. Provide input to costing algorithms, particularly at the customer level.
+ Attend customer meetings and lead discussions of project requirements and strategic planning.
+ Ensure compliance of work with project's scope of work.
+ Actively assess and help manage project realization.
+ Ensure project milestones are met according to agreed upon timelines with high quality.
+ May serve as a Data Management Customer Liaison for one or more customers.
+ Manage staff in accordance with organization's policies and applicable regulations.
+ Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
_All responsibilities are essential job functions unless noted as nonessential (N)._
**REQUIRED KNOWLEDGE, SKILLS AND ABILITIES**
+ Advanced knowledge of Data Management processes and systems
+ Solid understanding of clinical drug development process and production of DM deliverables
+ Strong project management, strategic planning, delegation and organisational skills. Proven ability to work on multiple projects and manage competing priorities
+ Strong business acumen; financial management and budgeting skills.
+ Proven Staff management skills, strong leadership, motivational and influencing skills.
+ Outstanding written and oral communication skills
+ Proven leadership skills
+ Outstanding problem-solving skills
+ Excellent interpersonal skills
+ Strong customer focus and experience in customer contracting models
+ Ability to establish and maintain effective working relationships with co-workers, managers and clients
**MINIMUM REQUIRED EDUCATION AND EXPERIENCE**
- Bachelor's degree, or educational equivalence, in clinical, biological or mathematical sciences or related field, or nursing
qualification with 10 years of relevant work experience including substantial people management experience; or
equivalent combination of education, training and experience
**PHYSICIAL REQUIREMENTS**
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled

The Sr. CDM will lead and contribute to data management activities in support of Client's studies across all stages of clinical drug development.
**Summary of Key Responsibilities**
+ Contribute to data management activities as a lead study data manager in support of Client's clinical studies
+ Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing
+ Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews
+ Oversight of database lock activities and ultimate archiving of study data
+ Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors
+ Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews
+ Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation
+ Contribute to development and implementation of department workflows and infrastructure strategy (such as preferred provider interactions, SOPs, and templates) that reflects data collection standards, consistent with industry best practice and regulation
+ Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
+ Participate in the training of external vendors and site staff
+ Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met
+ Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
+ Support GCP inspection readiness
**Qualifications**
+ BS/BA in scientific discipline,
+ At least 7 years related experience in a pharmaceutical/biologics/biotechnology company
+ Experience working in clinical drug development through Phase 3 in an outsourced CRO model; experience with drug development in rare genetic diseases preferred
+ Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems
+ Knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH
+ Experience working with Medidata Rave
+ Experience using standardized medical terminology, including MedDRA and WHODrug
+ Experience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS Project
+ Excellent written and oral communications skills
+ Highly motivated and flexible, with excellent organizational and time management skills
+ Ability to work independently and as part of a multi-disciplinary team
+ Understanding of ICH GCP as well as general knowledge of industry practices and standards
+ Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
+ NDA/MAA experience
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled