Contract Clinical Trial Management Associate
An international staffing and recruiting company is currently recruiting a Contract Clinical Trial Management Associate to join their office in the UK. This organisation is one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors. This is an exciting opportunity to work with a firm dedicated to innovative and dynamic approaches to the changing workforce landscape.
- Meeting all requirements for Clinical Trial Management Associate position and have demonstrated proficiency in all relevant areas.
- Managing European Country components of Phase 2 or 3 trials as a member of the study team.
- Coordinating CROs or vendors as required and demonstrates 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, RMVs) with CRO CRAs to ensure correct study procedures according to company SOPs and protocol procedures, and review of 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.
- May be asked to assist in the training of Clinical Trial Management Associates and Clinical Project Assistants.
- May coordinate the preparation and organization of international investigator meetings
- Assisting in the preparation of safety, interim, and final study reports, including resolving data discrepancies.
- Travel is required up to 10- 20%.
Skills and Requirements:
- A BSc or BA in a relevant scientific discipline or RN qualification.
- Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.
- Must have a general understanding of functional issues and routine project goals from an organizational perspective
- CRA experience preferred.
- Inflammation experience preferred but not essential.
- Must be familiar with routine medical/scientific terminology.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
- Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision as required.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Matthew Pike at +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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