Senior Clinical Data Manager – FSO

🕒 September 21

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 19%

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Serve as the technical leader on all data management aspects for projects, including start-up, maintenance, and completion activities • Develop global Data Management Plans and Quality Management Plans • Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts • Serve as project and client liaison, managing and providing project-specific data management status, cycle time, and productivity metrics • Coordinate and participate in development of the clinical data model and/or database design and annotate CRFs/eCRFs • Review data acquisition conventions, data review guidelines, and diagnostic specifications • Coordinate development and testing of data management system edit/data validation checks, diagnostics, and special listings/procedures • Collaborate with clinical, programming, statistics, CDM technical support, drug safety, and other project and specialty teams • Lead advanced planning and risk management, including issue escalation and resource management • Oversee technical performance of data review project staff and delivery of quality data on time and on budget • Assist with goal creation and performance review assessments for data review project staff • Maintain technical data management competencies through internal and external training seminars • Ensure project staff are trained and adhere to project-specific and global standardized data management processes • Identify process and efficiency improvements and implement solutions • Support achievement of project revenue and operating margin targets for data management activities • Support business development through data management time and cost estimates and presentations to potential clients

🎯 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) • Additional relevant work experience will be considered in lieu of formal qualifications • Lead experience across a mix of therapeutic areas especially across Late Phase (IIb-III) trials • EDC experience; ideally RAVE experience, with experience across other EDCs advantageous • 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 project teams on project strategies and achievement of department goals, objectives, and initiatives • Willingness to encourage team members to seek solutions

🏖️ Benefits

• 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