Senior Manager, Clinical Data Management

Eikon Therapeutics is a biopharmaceutical company seeking a Senior Manager, Clinical Data Management to lead clinical data management deliverables supporting the Eikon portfolio. The role requires onsite presence in either California or New Jersey offices and a strong track record of delivering high-quality data in fast-paced clinical development environments.

Requirements

• Post Graduate degree with 6+ years of experience or a Bachelor's degree with 8+ years of experience in a relevant field such as Life Sciences, Biostatistics, Computer Science, or a related discipline.
• Proven experience in clinical data management gained from working at recognized clinical data management suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic, and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
• Prior experience supporting oncology clinical trials is required.
• Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management.
• Sound knowledge of EDC systems (Veeva CDMS preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection.
• Strong project management; Exhibits expertise in metrics analysis and reporting methodologies.
• Excellent oral and written communication skills.
• Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)].
• Deep knowledge of CDASH/CDISC (CDASH CRF Library implementation experience is preferred).