Senior Clinical Data Manager
Skills
- Extensive Clinical Data Management (CDM) experience with EDC systems
- Strong knowledge of ICH/GCP, 21 CFR Part 11 and clinical trial methodology
- Proven project management and team leadership skills
- Experience with data reconciliation (IVRS, lab) and reporting/metrics
- Excellent verbal and written communication skills
- Proficiency in Microsoft Office (MS Project, MS Excel)
Responsibilities
- Act as primary data management representative and sponsor liaison for assigned studies
- Lead study planning, oversee timelines, and ensure timely completion of deliverables
- Create and oversee database design specifications, edit checks, and validation activities
- Manage data cleaning, query processing/resolution, and vendor data reconciliation
- Oversee internal system testing (IST) and compile sponsor UAT packages
- Develop and review data management documents (DMPs, eCRF guidelines, CRFs, help text)
- Provide data management reports, metrics, and custom reporting specifications
- Coordinate database freeze/lock activities and maintain study documentation
- Mentor and delegate work to junior data management staff and provide ongoing guidance
- Participate in study kickoff, investigator meetings, training, closeout and lessons learned
Education
- Bachelor’s degree in Pharmaceutical, Biotechnology, or health-related field preferred
- Advanced degree (MS, MPH, PharmD) considered a plus
- Relevant CDM certifications or training advantageous
Benefits
- Remote-first work model with flexible work arrangements
- Health, dental, and vision insurance (typical employer-sponsored benefits)
- 401(k) retirement plan with potential employer match
- Paid time off, holidays, and parental leave policies
- Professional development, training and career growth opportunities
- Inclusive culture and award-winning workplace recognition
Average salary estimate
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Founded in 2012, eClinical Solutions is a data intelligence hub that provides clinical data management solutions. They offer eGrex, a cloud-based clinical data repository, which enables life sciences organizations to optimize the aggregation, stan...
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