Senior Clinical Data Manager – Sponsor Dedicated

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Provides leadership in Clinical Data Management (CDM) for one or more assigned projects or indications based on the project's size and scope.

• Holds global accountability and acts as the secondary point of contact at the project level.

• Leads studies that may include a combination of healthy volunteers and patient populations, multi-site engagements, complex protocol designs, strong client management requirements, or shortened timelines.

• Demonstrates the ability to organize effectively and prioritize workload and deliverables.

• Exhibits leadership and operational proficiency in the strategic planning and execution of CDM deliverables at the program and/or project level.

• Manages and oversees vendor contracts, resource allocation, budget management, and vendor performance for assigned programs and projects.

• Communicates and negotiates effectively with all other team members at the program level.

• Serves as the primary contact for Clinical Data Management (CDM).

• Shows a comprehensive understanding of the compound profile to identify and support the consistent application of CDM processes and documentation across assigned programs, ensuring consistency in data quality plans.

• Provides oversight and expertise for external service providers or in-house teams to deliver quality data in compliance with study model procedures and standards; offers guidance on company standards, processes, systems, and expectations to external partners, internal partners, and third-party vendors.

• Responsible for proactive risk management and issue resolution/escalation related to Clinical Data Management improvements or technology.

• Develops an understanding of CDASH and SDTM or other recognized industry standards and their impact on the programming team to ensure adherence to program-level standards.

• Acts as a specialist in therapy area-specific data capture and standards, conducts lessons learned, and shares insights across the organization as appropriate.

• May serve as a team leader or mentor for Clinical Data Management colleagues and stakeholders involved in operational processes for studies and projects.

• Displays a willingness to take on and lead any project-level activities aligned with current experience to support study delivery.

⛳️ Requirements

• University/college degree in a life science, pharmacy, or related field preferred, or certification in a related allied health profession from an accredited institution (e.g., nursing certification, medical or laboratory technology).

• 8 years of combined experience in early or late-stage Data Management, with a minimum of 2 years in direct sponsor management and at least 2 years of technical mentoring experience.

• Proven expertise in managing customer negotiations and experience with managing Scope of Work and budgets.

• Extensive experience in clinical data management and in leading studies within a CRO/Pharma environment.

• Excellent verbal and written communication and presentation abilities.

• In-depth knowledge of the clinical trial process, data management, clinical operations, biometrics, quality management, and systems applications to support operations.

• Familiarity with the relationship and regulatory obligations of the CRO industry in relation to pharmaceutical and biotechnological companies.

• Ability to lead teams by example in project strategies and achieving departmental goals, objectives, and initiatives, while encouraging team members to pursue solutions.

• Demonstrated managerial and interpersonal skills.

🏝️ Benefits

• Engaging and meaningful work within an established, diverse, and highly profitable global company.

• Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances, and more.

• A genuine work-life balance.

• Flexibility in working hours.

• Comprehensive onboarding with support from a personal mentor.

• A permanent employment contract with Fortrea Drug Development and opportunities for rewarding career progression.