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Clinical Trials Manager
2 months ago
Clinical Trials Manager - Oncology 12 month contract Location Stockley Park (3 days onsite required) An experienced CTM with extensive oncology (preferably solid tumours) experience.Experience in Primary Analysis and data analysis in general - Familiar with PFS and OS analysis, imaging management in oncology Clinical trials, ePRO management.
POSITION OVERVIEW
Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all therapeutic areas. Clinical Operations plays a key role in ensuring all clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of products.You will manage a geographical region(s) of assigned clinical studies or multiple components of larger studies. You will typically manage Phase I studies or other smaller studies. You will define and incorporate study logistics and study plans to accomplish clinical study objectives. You may also participate in strategic initiatives.Key Skills
- PharmD / PhD with 2+ years’ relevant clinical or related experience in life sciences
- MA / MS with 3+ years’ relevant clinical or related experience in life sciences
- BA / BS / RN with 5+ years’ relevant clinical or related experience in life sciences
- Multiple years’ clinical or related experience in life sciences, including experience leading or managing less complex studies and project teams
- Experience managing the work of external vendors.
- Meets all requirements for Senior Clinical Trial Management Associate (Senior CTMA)
- Ability to manage any component of full cycle study management, from start-up to close-out
- Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.
- Fully understands protocol requirements and effectively articulates and interprets these
- Thorough knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies
- Familiar with standard medical / scientific terminology.
