Senior Manager, Clinical Data Management
2 weeks ago
At 89bio, we are seeking a highly skilled Senior Manager, Clinical Data Management to join our team. As a key member of our clinical development team, you will be responsible for overseeing data management activities across multiple clinical trials, ensuring the accuracy, consistency, and completeness of clinical databases and filed documentation.
Key responsibilities include:
- Overseeing data management activities to maintain consistency across trials, including Case Report Form (CRF) design, Data Management Plans, CRF annotation, edit check programs, data entry, and query status tracking.
- Proactively identifying risks and executing risk mitigation strategies, maintaining timely communication with upper management and cross-functional teams.
- Overseeing database design, migration, or expansion, including UAT and documentation.
- Supporting cross-functional activities related to biometrics, regulatory submissions, and clinical program development as needed.
Requirements include:
- BS degree in a life science or related field preferred.
- Minimum of 5+ years of CDM experience in biotech or pharmaceutical industry; or equivalent education and experience required.
- Ability to manage multiple programs and studies within a program.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities.
- Experience supporting Phase 3 studies, BLA submission, and FDA/MHRA audits.
- Proficient in CDMS (e.g., Medidata, Clintrak), Microsoft Office Suite (e.g., Word, Excel, PowerPoint).
- Understanding of the principles of clinical research (e.g., ICH GCP, CDISC, and GCDMP).
Benefits include:
- Competitive health insurance coverage.
- Generous PTO allowance.
- 401k match.
- Employee Stock Purchase Plan (ESPP).
- Commuter Benefits.
- Women's forum/mentoring.
- Office based in the heart of San Francisco, near plenty of shops and restaurants.
- Fun opportunities to engage with coworkers in-person and remotely.
89bio is an equal opportunity employer and welcomes applications from diverse candidates. Proof of Covid vaccination is a condition of employment. Please note that 89bio does not accept unsolicited resumes and asks that employees, hiring managers, and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team.", "company": "89bio", "location": "San Francisco"}
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