Data Operations Manager
1 week ago
Boston-based recruitment agency Barrington James seeks a seasoned Senior Clinical Data Manager to join their dynamic team.
Job Description:This key role demands a highly experienced professional with 7+ years of expertise in clinical data management, particularly in Biotech and regulatory compliance. The successful candidate will be responsible for managing day-to-day data management activities, collaborating on study start-up activities, and ensuring timely delivery of accurate study status updates.
Based on industry standards and the location, we estimate the salary for this position to be around $120,000 per year.
Key Accountabilities:- Manage day-to-day data management activities for the CRO, prioritizing tasks and resources to meet project deadlines
- Collaborate with cross-functional teams to develop and review database specifications, competition guidelines, Data Management Plans, and data validation specifications during study start-up activities
- Provide regular study status updates, highlighting potential data management risks and suggesting mitigation strategies
- Minimum 7+ years of experience in clinical data management
- Substantial experience in Biotech (at least 3+ years)
- Proven track record in FDA / Regulatory compliance
- Advanced skills in Medidata Rave (5+ years) - Database Builds / Study Start up / DB Locks
- Familiarity with PII / PIII clinical trials essential
- Previous CRO oversight experience
- Excellent communication, teamwork, and problem-solving skills
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