Clinical Data Manager
Title: Clinical Data Manager
Duration: 6 Months to Perm
Location: Home Based- Remote
Hours expected: 40 hours per week
Day to Day Duties/Responsibilities/ Scope of Work:
- Technical leader for start-up, maintenance, and completion activities and develop [Global] Data Management Plans and Quality Management (QM) Plan.
- Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
- Coordinate the development and testing of data management systems edit data validation checks) diagnostics) and special listings I procedures used as tools for the data review and discrepancy management activities.
- Review data acquisition conventions and data review guidelines, diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion.
- Minimum five (5) years relevant work experience in data management with approximately one (1) year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
- Demonstrated skill for technical management of staff exceeding 5 employees.
- Excellent oral and written communication and presentation skills.
- In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
- Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.
- Ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
- Demonstrated managerial and interpersonal skills.
Sthree US is acting as an Employment Business in relation to this vacancy.