Clinical Project Manager - Senior Clinical Research Associate

Recruiter
Chiltern
Location
Gloucestershire
Posted
23 Jan 2018
Closes
14 Mar 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Job Background The company is officially certified by the Top Employers Institute for its exceptional employee offerings for the fourth consecutive year, and for the first time, Top European Employer Therpay area coverage will be Neuroscience and Ophthalmology Competitive salary and benefits Full support and a focus on development Free access to training Great team of people Would suit a senior CRA who wants project management or a seasoned project manager who misses the monitoring and would like to get back into some site interaction. We will consider full time or 4 days/week Permanent employment with Chiltern - seconded to a top ten pharmaceutical company 12 Months rolling contract PAYE salary and a wide range of company benefits. One of our Clients is a top ten pharmaceutical company. They are looking for a Senior CRA/Junior Project Manager - ideally they are looking for an experienced and able CRA with some knowledge of Project Management or a Project Manager who misses monitoring and would like some site interaction. Sites will be along the M4 corridor area. THIS IS A PERMANENT position with CHILTERN - NOT FREELANCE. This is a salaried position on PAYE. Salary will be early to mid-40s (depending on experience) plus car allowance/month or car and extra benefits such as 25 days leave (increases to 30 over time), Pension, LI , Healthcare contributions and a range of other benefits. Chiltern and our Pharma Partner have an excellent strategic relationship offering the successful candidate career progression/development opportunities, dedicated line management, free access to training and full admin/HR and fleet support. The successful candidate will be heavily involved in early phase/translational medicine trials that are run on behalf of their IBR (Institute for Biomedical Research) as well as the smaller global development studies of 5 centers or less, including paediatric studies. Studies will be across all therapeutic area, phase I to III and often in new indications to the company and orphan diseases, they also tend to be complex but scientifically interesting protocols. The role involves project management and monitoring of trials, CPMs either manage and monitor their own studies or monitor another CPMs studies alongside their own project management. Location - monitoring allocation will be national so someone close to good transport links is a necessity. For this role the M4 Corridor would be ideal. It's a field based position so could be anywhere but most sites are in England, especially the South/London. If you are close to Frimley (junction 4 of the M3) they'd welcome you in the office as often as you'd like! DUTIES Act as Clinical Study Manager and CRA for allocated clinical trials. Provide a central point for communication between global (US/Basle), UK Trial Team and Investigators. Responsible to Head of ICRO for delivery of clinical trial ICRO performance metrics. Responsible for the management of trials to timelines, budget and for the delivery of ICRO metrics. Direct and lead the trial team, cascade milestones to ensure trials undertaken meet or exceed target. Leads centre selection in conjunction with ICRO, Medical (including MDA team), Marketing, Sales and selects an appropriate numbers of KOLs. Provide protocol training to trial team members. Write and coordinates ethics submissions and attends ethics committee meetings. Communicates clearly with regulatory department regarding local regulatory submissions for CTAs. Coordinate and attend investigator meetings. Negotiate contracts with CROs, SMOs and NHS trusts as required. Develop recruitment strategies and contingencies in conjunction with CRAs and Medical Affairs Team. Develop and maintains relationships with KOLs and investigators. Facilitate preparation and collection of site level documents. Execute site initiation and training activities. Perform monitoring visits according to monitoring plan. Assure continual GCP, ICH and SOP compliance (Informed consent process, Source data verification, AE and SAE reporting, protocol, drug accountability etc.). Resolve deviations to protocol and standard processes by remedial action and training. Author study monitoring reports and review of study monitoring reports completed by team member. Ensure interim and end of study data cleaning activities are completed by study sites within set timeline. Execute site and study closeout activities. May act as global CRA Lead, as assigned. REQUIREMENTS Scientific of healthcare discipline. Languages: English written and spoken Ideally 2+ years pharmaceutical industry experience with 4 years’ strong experience in clinical research. Experience in a monitor role or a role overseeing clinical trials Strong Interpersonal skills Strong Project Management skills Working experience in a global team, team player Ability to work under pressure Ability to work in a matrix environment Salary On Application Position Type Permanent Full Time or Part Time Contact Email Marc Joseph - marc.joseph@chiltern.com 01753 216664

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