Senior Clinical Data Manager – FSO

🕒 il y a 15 jours

🇬🇧 Royaume-Uni – Télétravail

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 10%

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🗣️🇺🇸🇬🇧 Anglais requis

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Fortrea

10 000+ employés

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

Healthcare • Biotechnology • Pharmaceuticals

Fortrea est une organisation de recherche clinique (CRO) avec plus de 30 ans d'expérience, dédiée à accélérer le développement de traitements révolutionnaires en fournissant des solutions cliniques complètes pour les entreprises de biopharmacie et MedTech. Ils offrent une gamme de services incluant la gestion des essais cliniques, les services de pharmacologie, et la stratégie réglementaire, tous conçus autour des besoins de leurs clients. La mission de Fortrea est de placer les patients au cœur de leur travail, visant à apporter des thérapies innovantes sur le marché plus rapidement grâce à des approches personnalisées et basées sur les données.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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

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