Clinical Trial Manager
1 month ago
Global Pharma are looking to recruit an experienced Clinical Study Manager with strong Oncology (ideally solid tumours) experience in Primary Analysis and data analysis in general - Familiar with PFS and OS analysis, imaging management in oncology Clinical trials, ePRO management
12 month initial contract - Hybrid role, Inscope
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.
• Manages all components of small clinical studies, including Phase I studies.
• May lead/support contract research organization (CRO) and vendor selection and, where applicable, manages all interactions and deliverables from relevant CROs and vendors.
• Typically serves as the key operational contact providing oversight for the site evaluation, initiation, and close-out visits in addition to routine monitoring visits, either directly or through CROs.
• Defines and develops the study logistics and clinical study plan for assigned clinical studies.
• Manages study timelines, including documentation and communications.
• Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams.
• Contributes to SOP development and/or participates in special projects. Develops tools and processes that optimize project efficiencies and effectiveness.
• Provides input into study protocols and case report forms, authors informed consents, study plans, and presentations.
• Provides oversight of study sites/region and reviews routine regulatory documents to ensure that CROs are in compliance with protocols, regulatory requirements, SOPs, and monitoring plans.
• May be required to present at internal or external meetings (i.e., investigator meetings).
• Leads or otherwise assists in the preparation of safety, interim and final study reports, including resolving any data discrepancies.
• Proactively identifies potential operational challenges and collaborates with other Clinical Operations’ colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.
• 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.
Please send CV
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