Clinical Study Management Associate

Up to £350 per hour
  1. Contract
  2. Clinical Research Associate (CRA)
  3. United Kingdom
Uxbridge, Middlesex
Posting date: 18 Feb 2019
CR.MP.21744_1550488100

ProClinical is announcing a new vacancy for a Clinical Trial Management Associate position with an international biopharmaceutical company that prides itself on its work in scientific research and late-stage drug testing. This organisation, which has a solid commercial portfolio of life-saving drugs, is seeking for a talented and experienced incumbent to join their team in Uxbridge on a contract basis.

The Clinical Trial Management Associate will execute Phase I-IV clinical trials across all therapeutic areas around the world. They will partner with Clinical Research, Clinical Operations, Medical Affairs, and other Development Operations functions to ensure that all clinical trial activities are performed in accordance with applicable SOPs, company policies, and regulatory guidelines. The CTM Associate will provide timely data to support global registration and commercialisation of company products.

Job Responsibilities:

  • Managing European Country components of Phase II-III trials as a member of the study team.
  • Coordinating CROs or vendors as required and demonstrating an ability to work independently.
  • Providing assistance in site selection, study implementation, and ongoing coordination of study sites, either directly or via CROs.
  • Assisting global trial managers with set-up of central labs and study vendors as required, including liaising with study management CRO to ensure site training and timely initiation.
  • Performing accompanied visits (PSSVs, SIVs, RMS) with CRO CRAs to ensure correct study procedures according to company SOPs and protocol procedures and reviewing routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
  • Assisting in the review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts, and clinical study reports.
  • Reviewing trip reports generated by CRO CRAs.
  • Communicating and collaborating with other functional groups, including but not limited to Clinical Research, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.
  • Assisting in the training of Clinical Trial Management Associates and Clinical Project Assistant.
  • Coordinating the preparation and organisation of international investigator meetings.
  • Assisting in the preparation and organisation of international investigator meetings.
  • Assisting in the preparation of safety, interim, and final study reports, including resolving data discrepancies.

Skills and Requirements:

  • A BSc or BA in a relevant scientific discipline, or RN Qualification.
  • Demonstrable clinical trial experience in the pharmaceutical or health care industry or equivalent.
  • Demonstrable CRA experience.
  • A strong knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
  • Experience with inflammation a preferred, but non-essential, bonus.
  • A strong familiarity with routine medical/scientific terminology.
  • Proficiency with MS Office Suite.
  • A general understanding of functional issues and routine project goals from an organisational perspective.
  • An ability to identify solutions to study issues based on precedent.
  • Strong interpersonal skills, including communication, presentation, and persuasion.
  • Capability of communicating with executives and driving alignment on common objectives.
  • Strong organisational skills, including the ability to work in a fast paced environment with a flexible approach, proactivity, optimism, pragmatism, and drive.
  • Fluency in spoken and written English.
  • A positive attitude and strong work ethic.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matthew Pike on + 44 207 440 0639 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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