Responsibilities
- 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 company Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence
- Performs other duties as assigned
- May involve travel
Requirements :
- BS / BA in scientific discipline, MS or equivalent preferred, with at least years related experience in a CRO / pharmaceutical / biologics / biotechnology company
- Study / Vendor oversight experience
- Expert knowledge of Data Management 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 EDC data management systems
- 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 CFR Part
- Highly motivated and flexible, with excellent organizational and time management skills
- Ability to work independently and as part of a multi-disciplinary team
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