Clinical Data Manager

The CDM will contribute to data management activities in support of studies across all stages of clinical drug development. Working within the environment of a biopharma company, handling in-house data work and review of vendor work. This position reports to the Associate Director, Data Management.

Summary of Key Responsibilities:

• Contribute to data management activities in support of clinical studies, including:

  • eCRF development by leading cross-functional reviews of eCRF content

  • Database build activities, including review of edit check specifications and performance of user acceptance testing

  • Monitoring 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, Drug Safety and Pharmacovigilance; 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, edit check specifications, external data transfer specifications and other study documentation

• 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 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 

• Demonstrate clear alignment with Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence

Qualifications:

• BS/BA in scientific discipline with over 4 years related experience in a pharmaceutical/CRO setting

• Strong 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 EDC

• Experience using standardized medical terminology, including MedDRA and WHODrug

• Experience working with MS Office Suite (Excel, Word and PowerPoint) and familiarity with MS Project

• Highly motivated and flexible, with excellent organizational and time management skills

• 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

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We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

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