Associate Director - Clinical Data Management

November 25

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• Manage data manager to ensure staffing and operational aspects are aligned with strategic business objectives. • Develop, improve, and/or refine data management processes and supporting documentation. • Organize the workload of team members across registry studies to ensure deliverables are met. • Supervise and lead data managers and activities supporting clinical registries from start-up through revisions. • Compile and manage CDM documentation to ensure master files are up-to-date and audit ready. • Participate in design/review of new/revised forms and oversee new EDC builds. • Contribute to project budget, resource planning, tracking CDM metrics/milestones, and ensuring data quality.

Requirements

• 7 or more years' experience within Clinical Data Management in biopharmaceutical/biotech, or CRO setting. • 3 or more years' in a supervisory or leadership role. • Proven ability in core DM activities, processes, and documentation. • Excellent communication skills to support effective interactions. • Extreme attention to detail and ability to multitask with strong prioritization, planning, and organization skills. • Advanced proficiency in Microsoft Office Suite. • Prior experience in the pharmaceutical, biotechnology, medical device/diagnostic, or clinical trial industries. • Strong knowledge of FDA Title 21 CFR Part 11. • Dedication to process improvement while producing high quality work within required timelines. • Strong English communication and writing skills.