2h ago
Clinical Data Manager
Burlington, MA
$145,000-$160,000 / year
full-timesenior Hybridbiotechnology
Tech Stack
Description
You will lead clinical trial data management activities, ensuring data integrity and accuracy from study start-up to database lock. Collaborate with cross-functional teams to support drug development for central nervous system disorders.
Requirements
- Bachelor's in life sciences, computer science, or related field
- 5+ years clinical data management in pharma/biotech
- Proficiency in Medidata Rave EDC system
- Strong understanding of GCP, FDA/EMA regulations, CDISC standards
- Excellent communication, organizational, and problem-solving skills
Responsibilities
- Manage all aspects of clinical trial data management from start-up to database lock
- Develop and implement data management plans and validation plans per regulatory standards
- Oversee Medidata Rave EDC system setup, configuration, and user management
- Perform data cleaning, discrepancy management, and reconciliation activities
- Lead data review and generate quality metrics for regulatory submissions
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