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Job Details

Clinical Project Manager - Senior Clinical Research Associate

Company: Chiltern
Location: Ideally South East but we will consider anywhere in the UK
Reference: MLJ899773
Closing Date: 21 Oct 17
Type: Permanent
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

This role would suit a Clinical Project Manager who misses the monitoring/site interaction OR a SCRA with some project management experience. The role will involve project management of very small complex studies with relatively small patient populations. You will project manage these studies and also you will monitor these very interesting niche trials. You will be EMPLOYED by CHILTERN and SECONDED TO the UK operations group of a top pharmaceutical company.

Requirements:

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
Wide therapy area coverage within general medicine and oncology
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.

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

Apply for this job: Clinical Project Manager -  Senior Clinical Research Associate

Contact Information:

Address:  London, UK
171 Bath Road Slough Berkshire
SL1 4AA, UK
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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