My client is a leading Bio-Pharma organisation based in West London
They are seeking a Senior Clinical Trial Management Associate on a 12 month contract. The role will involve assisting global trial managers on Phase Ib-III clinical studies, with a strong emphasis on the EMEA region.
The successful candidate will be a member of the Global Study team overseen by a Clinical Program Manager. You will work across several studies, including involvement from study start-up through study close-out activities, and will work with the CRO to execute the study to agreed timelines and budget. Essential Duties and Job Functions:
- Must meet all requirements for Clinical Trial Management Associate 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
- 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
- Performs accompanied visits 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
- Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, study plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures under close supervision.
- Review of trip reports generated by CRO CRAs
- Communicates and collaborates with other functional groups including but not limited to Clinical Research, Regulatory Affairs, Development Business Operations (DBO), Clinical Supply Management (CSM) and Pharmacovigilance (PVE) to ensure efficient management of study activities
- Assists with the preparation and organization of international investigator meetings
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
- Performs administrative duties in a timely manner as assigned
- Travel is required up to 20%
Experience, knowledge and skills:
- Educated to degree level or equivalent within a relevant scientific discipline
- Minimum 3 years relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.
- CRA experience preferred.
- 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.
Parkside Recruitment Ltd is acting as an Employment Business in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.