CLINICAL TEAM MANAGER (CTM) - Reading, United Kingdom (Office Based)

Recruiter
PRA Health Sciences
Location
All Saints
Posted
17 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
CLINICAL TEAM MANAGER (CTM) Location: Office Based in Reading As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs. At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace. At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 13,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community. Responsibilities: Working within one of PRA’s client-dedicated programs you will be fully Aligned to one sponsor, performing your role in accordance with their clinical SOP’s, with access to their internal systems and technology platforms. The Country Lead monitor is responsible for the country level management of 1-2 sponsor-led studies from start up to close out, and for communicating the progress and status of the studies to the sponsors’ global management team. Key responsibilities include: Taking full ownership of 1 larger or several small studies at a country-level from country feasibility to study archive, to include all aspects of site management and monitoring. Preparing the core country documents for successful study initiation, enrollment and maintenance. Training CRA’s on all aspects of the study, performing occasional co-monitoring visits and reviewing trip reports. Identifying country-level study issues and taking correcting action to ensure swift resolution to reduce impact on study data and monitoring activities. Responsibility for the reporting the country-level study initiation and monitoring progress in a monthly monitoring report, or on an ad-hoc basis as requested. You are: Dedicated, collaborative and inspire others. Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. 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. A background in monitoring on commercial clinical trials is preferred. Prior working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential. Willingness to travel to investigational sites, with occasional overnight stays when required. Prior exposure to budgets and feasibility within clinical trials is an advantage. Fluency in English is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively. You will be educated to Bachelors’ degree level, in a scientific subject area. 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. If you have any questions please email recruiteruk@prahs.com or call our recruitment department at +44 (0) 1189 213098 PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace. For more information please see our website: www.prahs.com-1

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