Senior Clinical Data Manager – Sponsor Dedicated
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Job Description
Senior Clinical Data Manager leading sponsor-dedicated clinical data management at Fortrea. Overseeing studies, vendors, budgets, data quality, standards, and client relationships.
Responsibilities:
- Provide Clinical Data Management leadership for one or more assigned projects or indications
- Take global accountability and serve as the second line of contact at project level
- Lead studies involving healthy volunteer and patient populations, multi-site studies, complex protocol designs, strong client management requirements, or reduced timelines
- Organize and prioritize workload and deliverables
- Plan and deliver Clinical Data Management deliverables at program and project level
- Manage and oversee vendor contracts, resourcing, budgets, and vendor performance
- Communicate and negotiate with program-level team members
- Serve as the primary point of contact for Clinical Data Management
- Apply consistent Clinical Data Management processes and documentation across assigned programs
- Oversee external service providers and in-house teams to deliver quality data in compliance with procedures and standards
- Provide guidance on company standards, processes, systems, and expectations
- Manage risks and resolve or escalate issues related to Clinical Data Management improvement or technology
- Develop understanding of CDASH, SDTM, and other recognized industry standards and their impact on programming teams
- Conduct lessons learned on therapeutic-area-specific data capture and standards and disseminate findings
- Mentor Clinical Data Management colleagues and stakeholders
- Lead project-level activities supporting study delivery
Requirements:
- University/college degree in life science, pharmacy or related subject preferred, or certification in a related allied health profession from an appropriately accredited institution
- 8 years of combined early or late-stage DM experience
- Minimum 2 years of direct sponsor management experience
- At least 2 years of technical mentoring experience
- Proven experience handling customer negotiations
- Experience managing Scope of Work and budgets
- Extensive experience in clinical data management
- Experience leading studies in a CRO/Pharma setting
- 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
- Working knowledge of the relationship and regulatory obligations of the CRO industry with pharmaceutical/biotechnological companies
- Ability to lead teams by example on project strategies and achievement of department goals, objectives, and initiatives
- Demonstrated managerial and interpersonal skills
Benefits:
- Highly competitive compensation packages
- Pension contributions
- Complimentary health insurance plans
- Remote working allowances
- Work life balance
- Flexibility in working hours
- Thorough onboarding with support from a personal mentor
- Permanent employment contract with Fortrea Drug Development
- Career progression
- Mentoring, training and personalized development planning
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