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Job Details

Lead CRA

Company: Chiltern
Location: Office based - Buckinghamshire, England, UK
Reference: NC900012
Closing Date: 22 Oct 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Employed or freelance - working office based in Buckinghamshire

Requirements:

Job Background

Our client a top pharma company provide transformational medical technologies and are looking for a Lead CRA to join their team in Buckinghamshire.

Candidates can either be employed on PAYE through Chiltern to work for our client OR work on a freelance basis for a maximum of 1 year.

Working on a large clinical cardiology trial the role will involve :-

Support with line management of a remote global team of CRAs including oversight of clinical studies: support project teams with planning & implementation of Clinical Trials in compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOP), Corporate Policies; Guidelines & Standards.

  • Train and oversee CRA contractors.
  • Responsible for managing site visit schedules, review and approval of site visit reports.
  • Manage study project plans and identify risks in meeting study milestones and to address resolutions of the issues with the project team as required.
  • Ensures that Serious Adverse Event (SAE) reports are provided to ensure compliance with reporting requirements.
  • Liaise with related functions/departments internally, e.g. Regulatory; Medical, Quality Assurance (QA);
  • Safety unit; Finance; Contracts; Legal and Compliance.
  • Review of study data and follow-up with Data Management, Clinical Operations, Safety, Medical, Sites
  • relating to electronic case report forms (eCRF).
  • Review of the e-Trial Master File (eTMF) and ensure it is up to date and accurate.
  • Attend site visits: Feasibility and Selection, Initiation, Monitoring and Co-Monitoring and Close-Out visits.
  • Ensures that the tracking system (patient recruitment; milestones; budget; vendor reporting) is up to date
  • Provide management with detailed reports of clinical studies activities, as requested.
  • Lead regular CRA and clinical project meetings and provide regular verbal and/or written reports to project and management teams on the clinical study progress.

 

Other Skills:

  • Good written and oral communication skills, as well as presentation skills.
  • Multi-lingual (European languages).
  • Good knowledge of MS Word, MS Excel, MS PowePoint.
  • Decisive attitude and the ability to work independently and systematically.
  • Good interpersonal skills, with communicative and flexible attitude to build good working relationships both internally and externally.
  • Ability to promote teamwork, to implement and co-ordinate all aspects of a clinical study, to accept responsibility for study objectives in terms of quality and timelines. 

Candidates should have a BSc and ideally have at least 5 years of experience in clinical research. Must have experience of conducting site visits (Feasibility, Site start-up through to site close-out) and have experience of managing a CRA team. Multi-lingual (European languages).

To apply for this position please email your CV to marc.joseph@chiltern.com - marc.joseph@chiltern.com or for a confidential discussion please call Marc on 01753 216664 

Candidates must be eligible to work in the UK

Keywords:  Lead CRA, Lead Clinical Research Associate

 

 

 

Salary

Negotiable

Position Type

Permanent or Contract
Full Time

Contact

Email Marc Joseph - marc.joseph@chiltern.com
+44 (0) 1753 216 664

Apply for this job: Lead CRA

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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