Senior Clinical Study Management Associate
ProClinical is advertising a vacancy for a 12-month contract position with a leading pharmaceutical company as a Senior Clinical Trial Management Associate. This organization prides itself on its solid commercial portfolio of life-saving drugs within several therapy areas. Based in the company's UK office, this is an exciting opportunity to work with an internationally renowned company and support their innovative impact on the healthcare field.
- Must meet all requirements for Clinical Trial Management Associate position and have demonstrated proficiency in all relevant areas.
- Manage European Country components of Phase 2 or 3 trials as a member of the study team
- Coordinates CROs or vendors as required and demonstrates an ability to work independently
- Aids in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- Assist 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.
- May assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
- 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
Skills and Requirements
- Typically requires 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.
- 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.
In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at 0207 440 0639 or upload your CV on our website - www.proclinical.com/send-cv