Senior Clinical trial Management associate
JOB_52954034658779Job type
ContractLocation
UxbridgeWorking Pattern
Full-timeSpecialism
Clinical ResearchIndustry
Scientific and R&DPay
Day rate
Clinical Trial Man Ass with Cell Therapy exp. 12-month contract
A biopharmaceutical company is recruiting for an Experienced Contract Senior Clinical Trial Management Associate
to work within the Oncology Disease/Cell Therapy therapeutic area. This is a
hybrid working structure of 3 days per week in the office.
Essential Duties and Job Functions:
Assist global trial managers with set-up of central labs and study vendors as required,
Performs accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs 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
Review of trip reports generated by CRO CRAs.
Communicates and collaborates 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.
Assists in the Management of the CRO’s and vendor’s as required.
Assists with the preparation and organisation of international investigator meetings
Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
Experience, knowledge and skills:
Educated to a degree level or equivalent in a scientific discipline
Previous experience of pharmaceutical clinical trial experience Essential
CRA experience is highly desired
Oncology experience is required / CAR-T Cell Therapy would be desirable
Excellent verbal, written, interpersonal and presentation skills are required.
Must be familiar with routine medical/scientific terminology.
Must be proficient with Word, PowerPoint, and Excel.
Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
- The candidate should be skilled in communication, time management, organisation, and prioritisation.
- Previous experience in clinical research sites/hospitals, CROs, or pharmaceutical companies is desirable.
- Knowledge of European regulations for clinical trials is desirable.
Please send your CV to Claire.helliwell@hays.com
This is a 12 month initial contract (3 days on site, inscope)
Senior Clinical trial Management associateJOB_529540346587792025-02-122025-05-14
Talk to Claire Helliwell, the specialist consultant managing this position
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JOB_52954034658779