Description
Join Fortrea's Clinical Data Management sponsor dedicated team as a Senior Clinical Data Manager, offering a rewarding career in a world-leading team. You will have exposure to high-profile global studies, a competitive compensation package, and a genuine work-life balance.
Responsibilities:
- Provide CDM leadership for assigned projects or indications
- Lead studies with complex protocol designs, multi-site, and strong client management
- Demonstrate leadership and operational expertise in strategic planning and delivery of CDM deliverables
- Manage vendor contracts, resourcing, budget, and performance for assigned programs and projects
- Communicate effectively with program-level team members as the primary point of contact for Clinical Data Management
- Provide oversight and expertise to external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards
- Proactively manage risks and resolve issues related to Clinical Data Management improvement or technology
- Develop an understanding of CDASH and SDTM standards and their impact on programming teams
Requirements:
- University/college degree in life science, pharmacy, or a related subject
- 8 years of combined early or late-stage DM experience with at least 2 years of direct sponsor management and 2 years of technical mentoring experience
- Extensive experience in clinical data management and leading studies in a CRO/Pharma setting
- Understanding of RECIST criteria
- Excellent oral and written communication and presentation skills
- In-depth knowledge of clinical trial processes, data management, clinical operations, biometrics, quality management, and systems applications
- Working knowledge of the relationship and regulatory obligations of the CRO industry with pharmaceutical/biotechnological companies