Clinical Trial Manager- Outsourced to Sponsor

Pharm Research Associates Limited ,
Reading, Berkshire
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Overview

Summary One thing we all have in common is the drive to produce great results for our clients and to advance treatment options available to patients worldwide. We always have a desire to keep seeking new and better ways to operate, to achieve these results. Enter: the Strategic Solutions Division. Leveraging the advantages of working for a top-5 CRO, whilst simultaneously working fully-dedicated to a leading pharma company, will guarantee that the results you help accomplish in drug development are matched by your own career achievements. Responsibilities As a Clinical Trial Manager, you will be dedicated to one of our global pharmaceutical clients; a client with which PRA shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market. Leading by example, you can set the standard of excellence and enjoy a challenging career in this exclusive program. The Clinical Trial Manager is responsible for the country-level management of one or two studies from feasibility to study archive, and for communicating the progress and status of the studies to other key players within the team. Adopting a quality-focus to your work on complex global studies, your main responsibilities will include: Owning the study planning, progress, quality and tracking, at a country level, with full accountability for the national CRA team Collaborating with other global study team members, reporting to them on study progress via monthly reports, or ad hoc as required Tracking study milestones to guarantee overall delivery Preparing the core country documents for successful study initiation, enrollment and maintenance, including the country enrollment plan Designing and delivering training to the CRA team to ensure quality site management and adherence to all applicable regulations Proactively identifying potential issues and implementing risk-mitigation plans to ensure successful study delivery Managing the country study budget Training CRAs on all aspects of the study, performing occasional co-monitoring visits and reviewing trip reports Delivering expert-level site management, taking full ownership of sites, to include all aspects of site management. Working consistently and efficiently in this role, no two days are the same as you collaborate with other study team members to bring these life-improving treatments to market. You are: Quality-focused, detail-orientated and a key contributor to success. To enable success in this position you will have: Prior experience of leading studies at a country-level, as a Study Manager or Lead CRA, particularly within feasibility, start-up and quality management A proven track record of success in site management and on-site monitoring A working knowledge of ICH-GCP guidelines and local and international regulatory requirements Prior exposure to budgets and feasibility within clinical trials is an advantage Degree educated in a life science discipline or international equivalent A flexible, open-minded and culturally-aware approach to your work Flexibility to work 1-2 days office based in Reading is required Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better. For more information please visit our website: www.prahs.com PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. This job was originally posted as www.totaljobs.com/job/89623606

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