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2017-43945

2017-43945

Title 
Clinical Team Manager
Job Locations 
-
United Kingdom
Posted Date 
12/21/2017

More information about this job

Overview

At PRA Health Sciences, providing innovative solutions for our clients is what we do. Side-by-side with our clients, we strive to move drug discovery forward, helping them to develop life-saving and life-improving drugs. PRA has more than 10,000 employees working in 80+ countries providing comprehensive clinical development services across all phases.

 

From full service clinical development to the pioneering Embedded Solutions™ model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace. 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 50+ such drugs.

 

Responsibilities

Working primarily office-based(with some home working flexibility) 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.

Qualifications

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:

 

Requirements:-

  • 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.

 



PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

 

 

 

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