An Exciting Contract Opportunity for Clinical Trials Manager (Oncology) with one of the Leading Biopharmaceutical Clients in UK
Job Title: Clinical Trials Manager (Oncology)
Location: Stockley Park , UK- Hybrid
Duration: 12 months contract
Description:
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.
Responsibilities:
- Manages all components of small clinical studies, including Phase I studies.
- Typically serves as the key operational contact for studies, 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.
Minimum Education & Experience
- 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.
- 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