Senior Clinical Data Manager
New
E
eClinical SolutionsPharmaceutical Biotechnology
Location: RemoteFull-TimeSenior
Salary110,000 - 130,000 USD per year
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Job Details
- Experience
- 8+ years in Clinical Data Management experience preferred
- Required Skills
- Project ManagementMicrosoft Excel
Requirements
- Bachelor’s degree in Pharmaceutical/Biotechnology or higher in health-related field preferred
- 8+ years in Clinical Data Management experience preferred
- Knowledge of ICH/GCP guidelines and 21 CFR Part 11
- Strong project management experience and project team leadership skills
- Experience with EDC and Clinical Data Management Systems
- Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
- Excellent verbal and written communication skills
- Ability to work planning and perform work delegation
Responsibilities
- Act as study lead for the oversight, maintenance, and management of clinical trial databases
- Serve as the primary liaison between company personnel and Sponsor personnel
- Oversee database design specifications, validation, data cleaning, and closeout activities
- Monitor study timelines and ensure adherence to deliverables
- Delegate tasks and provide guidance to study data management team members
- Develop and oversee data management documents including DMPs, eCRF Completion Guidelines, and CRFs
- Perform and oversee vendor data reconciliation, query resolution, and database lock activities
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