Clinical Data Manager
$130,000–$150,000 year
On-site · Waltham, Massachusetts, United States
Job Summary
Lead all study-specific data management activities for oncology clinical studies, collaborating with internal/external stakeholders and CROs to design/update CRFs and EDC systems, develop data management documents (e.g., Data Management Plans, eCRF guidelines), oversee database cleaning and lock activities, support SAE reconciliation and medical coding, develop data transfer agreements with third parties, and generate ad hoc data listings to support Safety Review Meetings and translational research; requires a Bachelor's degree and 5-8 years of data management experience in oncology, strong communication, vendor management, and knowledge of ICH/GCP/FDA guidance, with ability to lead a team in a fast-paced, matrix environment.
Required Qualifications
- Bachelor�s degree required
- 5 -8 years of experience managing data management activities to support oncology clinical studies
- Experience managing external resources such as vendors and CROs
- Excellent communication skills and ability to work in a flexible, matrix environment
- Advanced working knowledge of ICH, GCP, and other relevant FDA guidance�s
- Ability to drive a team-oriented environment, motivate and influence others, lead strategic discussions and interact with critical internal and external stakeholders
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