Senior Clinical Data Manager
$164,000–$205,000 year
HybridRedwood City, California, United States
Job Summary
Manage data management timelines and coordinate deliverables for assigned clinical trials, overseeing database setup, migrations, and User Acceptance Testing. Generate and review study documents including Data Management Plans, Case Report Forms, and protocols, while leading internal data review plans and coordinating cross-functional listings. Provide oversight of CRO and service provider activities, manage vendor relationships, and execute data reconciliation for Serious AEs and external sources. Represent data management in study team meetings, generate metrics and reports, and train internal and external team members on EDC systems and CRF guidelines. Proactively identify study risks, maintain inspection-ready documentation, and support statisticians in clinical trial report production.
Required Qualifications
- Bachelor's degree in health sciences, Life Sciences, Mathematics, Computer Sciences, or health-related field
- At least three years for CDM and five years for Sr. CDM of Data Management experience in the pharmaceutical or biotechnology industry
- Solid knowledge of clinical data management principles, clinical trials process and regulatory requirements
- Good working knowledge of ICH, FDA, and GCP regulations and guidelines
- Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)
- Knowledge of industry standards (CDISC, SDTM, CDASH)
- Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug
- Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
- Ability to handle multiple projects and prioritize effectively, well organized and detail oriented
- Proven ability to work both independently and in a team setting
Desired Qualifications
- CRO/Service provider management experience
- Prior oncology/solid tumor experience highly desired
- Working knowledge of statistical programming packages (e.g. SAS) is a plus
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