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Clinical Project Manager/SCRA - Bristol/Bath/Swindon/M4 Corridor

Company: Chiltern
Location: Bath - Bristol - Swindon- Newbury - Cardiff
Reference: MLJSCRACPM
Closing Date: 13 Mar 18
Type: Not Specified
Salary (£): On Application
Benefits: 25 days holiday (minimum), flexible benefits, car or allowance, pension, gym subscription contribution, health care benefits

Job Summary:

HOME BASED Clinical Project Manager/Senior CRA required - who can monitor/project manage complex and interesting small patient number studies (5 centers maximum). Location is M4 Corridor in the Newbury, Swindon, Bristol, Bath or Cardiff area. This role would suit an experienced CRA with some knowledge of Project Management or a Project Manager who misses monitoring and would like some site interaction. You would be employed by Chiltern and seconded to a top ten pharma company.

Requirements:

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 our clients' IBR (Institute for Biomedical Research) as well as smaller global development studies of 5 centers or less, including paediatric studies.

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

Therapy area coverage within Neuroscience and Ophthalmology (early phase and small complex studies)

Competitive salary and benefits

Full support and a focus on development

Free access to training

Home based from day one in Bath - Bristol - Swindon - Newbury - M4 Corridor

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

THIS IS A PERMANENT position with CHILTERN - salaried position on a PAYE basis.

Salary is negotiable (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.

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.

DUTIES

Act as Clinical Study Manager and CRA for allocated clinical trials.

Provide a central point for communication between global (US/Basel), 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.

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

PLEASE CALL Marc Joseph on 01753 216664 for further discussion or send your CV directly to Marc at marc.joseph@chiltern.com OR apply via pharmiweb.

Key words senior clinical research associate, clinical project manager, monitoring, clinical project management, CRA, SCRA, CPM, clinical study management

Apply for this job: Clinical Project Manager/SCRA - Bristol/Bath/Swindon/M4 Corridor

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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