Senior Clinical Data Manager
San Francisco Bay Area, CA
The Senior Clinical Data Manager is responsible for the coordination and delivery of Data Management contracted services on assigned projects.
The primary purpose of the clinical data manager is to provide data management study oversight and ensure CDM best practices are followed. They should be able to communicate with CROs and vendors effectively. Additionally, as the primary point of contact, they should be able to facilitate and provide data management updates in project team meetings.
Role and Responsibilities
- Develop data management plans that deliver accurate, timely and consistent clinical data. Build, review, and maintain clinical databases, data collection tools, and applications.
- Create, review, and maintain study documentation, such as Case Report Forms (CRFs) and Data Transfer Agreements (DTAs).
- Contribute to protocol development and review. Compile, analyze, clean, and validate clinical trial data.
- Identify and resolve discrepancies and issues with clinical data.
- Develop data management reports and monitor study status to ensure timelines are met.
- Represent the data management function to key internal and external stakeholders.
- Work collaboratively with clinical research and operations team to ensure accurate and complete data collection.
- Considered highly skilled and proficient in discipline.
- Conducts complex, important work under minimal supervision and with wide latitude for independent judgment. Education Requirements
- Bachelor’s degree (or international equivalent) and 6+ years of relevant experience.
- At least 8 years of clinical data management experience
- Experience running clinical trials outsourced to a CRO as well as managed in-house
- Knowledgeable in GCP, CDISC standards, clinical trial guidelines & Data Management Best Practices
- Ability to ‘wear many hats,’ and self-motivated to take on new challenges
- Track record of success in a deadline-driven and multi-task environment
- Well organized and detailed oriented