- Experience Level
- Experienced (non-manager)
Hobson Prior is seeking a Clinical Trial Manager Associate to join a global biopharmaceutical company based in the UK. A very patient-focused company, whose scientific research has resulted in 15 marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
- Accountable to 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 self-sufficiently.
- Support 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.
- Provides assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- Communicates and collaborates with other functional groups including but not limited to Clinical Research, Regulatory Affairs, CCF, Materials and Logistics, and Drug Safety and Public Health to ensure efficient management of study activities.
- Completes accompanied visits with CRO CRAs to ensure correct study procedures according to the company’s SOPs and protocol procedures.
- Review routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
- Review of trip reports generated by CRO CRAs.
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
- An ability to identify solutions to study issues based on precedent.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Ideally 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
- Inflammation experience preferred but not essential.
- CRA experience preferred.
- 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 initiatives under general supervision as required.
- Travel is required up to 10- 20%.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.