Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. We are recruiting a Senior Manager, Clinical Data Management to provide leadership in data management and support the Eikon portfolio.
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
- Oncology experience required
- Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
- Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management
- Strong knowledge and experience 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
- Communicate effectively with senior management and cross-functional teams
- Deep knowledge of CDASH/CDISC (CDASH CRF Library implementation experience is preferred)
- Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)]
Benefits
- 401k plan with company matching
- Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
- Mental health and wellness benefits
- Weeklong summer and winter holiday shutdowns
- Generous paid time off and holiday policies
- Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
- Enhanced parental leave benefit
- Daily subsidized lunch program when on-site
