Job Posting for Lead Clinical Data Manager at Katalyst Healthcares & Life Sciences
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 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
Ability to work independently and as part of a multi-disciplinary team
Salary.com Estimation for Lead Clinical Data Manager in Cambridge, MA
$89,321 to $111,587
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