Senior Clinical Data Manager – Sponsor Dedicated
Location
United Kingdom
Posted
5 days ago
Salary
0
Seniority
Senior
Job Description
Senior Clinical Data Manager – Sponsor Dedicated
Fortrea
• Provides CDM leadership for one or more assigned projects or indications dependent on size and scale of the project. • Takes global accountability and serves as the second line of contact at the project level • Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines. • Ability to organize and effectively prioritize workload and deliverables • Demonstrates leadership and operational expertise in the strategic planning and delivery of CDM deliverables at program and/or project level. • Management and oversight of vendor contracts, resourcing and budget management and oversight of vendor performance for assigned programs, and projects • Communicates and negotiates effectively with all other Program level team members. • Primary point of contact for Clinical Data Management (CDM) • Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent CDM processes and documentation across assigned programs, (i.e. ensuring consistency across data quality plans.) • Provide oversight and expertise of external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards; give 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 connected to Clinical Data Management improvement or technology • Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards. • Specialist in TA specific data capture and standards, conducts lessons learned and disseminate across the organization as appropriate • May act as a team leaders or mentor Clinical Data Management colleagues and any stakeholder with operational processes used in studies and projects. • Demonstrates willingness to take on and lead any project level activity consistent with current or experience in support of study delivery.
Job Requirements
- University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
- 8 years of combined early or late-stage DM experience with minimum 2 years of direct sponsor management and at least 2 years technical mentoring experience
- Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets.
- Extensive experience in clinical data management and 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 to support operations.
- Working knowledge of the relationship and regulatory obligation 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 and to encourage team members to seek solutions.
- Demonstrated managerial and interpersonal skills.
Benefits
- Rewarding and meaningful work in an established, diverse, highly profitable and respected global company
- Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.
- A genuine work life balance
- Flexibility in working hours
- A thorough onboarding with support from your personal mentor
- A permanent employment contract with Fortrea Drug Development and a rewarding career progression
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