Our client is a research-based biopharmaceutical company that develops innovative treatments in areas of unmet medical need. The company's therapeutic areas of focus include HIV/AIDS, liver disease, serious respiratory, cardiovascular, and metabolic conditions, cancer and inflammation. They are seeking to hire a Senior CTMA to join their UK team.
Led by a team of well-established Clinical Operations professionals, careers within the Clinical Operations team offers individuals the opportunity to develop their knowledge & experience rapidly whilst enjoying a supportive and team-focused working environment.
- Must meet all requirements for Clinical Project Assistant position and have demonstrated proficiency in all relevant areas.
- Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- Must be able to perform oversight site visits and able to monitors fairly routine study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
- Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures under close supervision.
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
- Active member of the study management team and supports clinical trial management execution.
- Travel is required up to 20-30%.
Education and Experience:
- Typically requires a BS or BA in a relevant scientific discipline or international equivalent.
- Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.
- CRA experience preferred.
- Therapeutic area experience preferred but not essential.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Must be familiar with routine medical/scientific terminology.
- Must be familiar with Word, PowerPoint, and Excel.
- 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 initiative under general supervision.
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 Jonathan Senior on +44 203 8569 334 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.