Skip to main content

Clinical Data Manager

aplique agora
Localizações: Durham, Carolina do Norte Full time R1284176

Job description

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

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

aplique agora

Junte-se à Rede de Talentos da IQVIA

Inscreva-se hoje e avisaremos quando houver vagas disponíveis que sejam compatíveis com seus interesses profissionais.

Junte-se à nossa rede
Top of page