Lead Clinical Data Manager
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Cambridge, MA 02139
Description:
Responsibilities
Requirements:
- 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 5 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 21 CFR Part 11
- Highly motivated and flexible, with excellent organizational and time management skills
- bility to work independently and as part of a multi-disciplinary team