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Senior Clinical Data Manager – Medical Device
FortreaLead Data Manager managing clinical data projects at Fortrea, ensuring quality and adherence to timelines. Providing mentorship and project leadership to team members during database lock processes.
About the role
Key responsibilities & impact- Data Management leadership on studies
- Responsible for the development of project documentation, system set-up, data entry, and validation procedures
- Assume responsibility for all DM activities from study start-up to database lock
- Act as subject matter expert (SME) for DM activities in relationship meetings with Sponsors
- Work directly with Sponsors to understand their requirements
- Provide guidance, mentoring, and training to DM staff
- Organize and effectively prioritize workload and deliverables
- Ensure all projects are carried out in strict accordance with protocols, SOPs, and GCPs
- Build timelines to meet contracted milestones
- Provide DM project team leadership and accountability
- Maintain awareness of other functional group deliverables to support risk and mitigation strategies
- Develop and maintain client relationships and review client satisfaction surveys
Requirements
What you’ll need- University / college degree
- Experience and/or education plus relevant work experience
- Fluent in English, both verbal and written
- 5-7 years of clinical DM experience
- Minimum of 3 years of hands-one clinical EDC system experience
- Thorough knowledge of the clinical trial process, DM, clinical operations, biometrics, and system applications to support operations
- Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotech or medical device companies
- Time management skills and ability to adhere to project productivity metrics and timelines
- Ability to work in a team environment and collaborate with peers
- Ability to mentor junior members of the department
Benefits
Comp & perks- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
- Potential travel for cross-site support or training needs
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
data managementproject documentationdata entryvalidation proceduresclinical EDC systemsclinical trial processbiometricsclinical operationsSOPsGCPs
Soft Skills
leadershipmentoringtrainingorganizationprioritizationcommunicationcollaborationtime managementclient relationship managementproblem-solving
Certifications
university degreecollege degree