Senior Clinical Trial Management Associate
A biopharmaceutical company is recruiting for a Senior Clinical Trial Management Associate to work within the Oncology Disease/Cell Therapy therapeutic area. This position has a hybrid working structure of 3 days per week in the office.
Essential Duties and Job Functions:
1. Assist global trial managers with set-up of central labs and study vendors as required.
2. Perform accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
3. Under supervision, 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.
4. Review trip reports generated by CRO CRAs.
5. Communicate and collaborate 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.
6. Assist in the management of the CRO’s and vendor’s as required.
7. Assist with the preparation and organization of international investigator meetings.
8. Assist in preparation of safety, interim and final study reports, including resolving data discrepancies.
Experience, Knowledge and Skills:
1. Educated to degree level or equivalent in a scientific discipline.
2. Previous experience in pharmaceutical clinical trial experience is essential.
3. CRA experience is highly desired.
4. Oncology experience is required; CAR-T Cell Therapy would be desirable.
5. Excellent verbal, written, interpersonal, and presentation skills are required.
6. Must be familiar with routine medical/scientific terminology.
7. Must be proficient with Word, PowerPoint, and Excel.
8. Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
9. The candidate should be skilled in communication, time management, organization, and prioritization.
10. Previous experience in clinical research sites/hospitals, CROs, or pharmaceutical companies is desirable.
11. Knowledge of European regulations for clinical trials is desirable.
Please send CV to claire.helliwell@hays.com.
This is a 12-month initial contract (3 days on site, in scope).
Seniority Level
Associate
Employment Type
Contract
Job Function
Science
Industries
Staffing and Recruiting and Pharmaceutical Manufacturing
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