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 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 organization of international investigator meetings

Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.

Experience, knowledge and skills:

Educated to 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, organization, and prioritization.

– Previous experience in clinical research sites/hospitals, CROs, or pharmaceutical companies is desirable.

– Knowledge of European regulations for clinical trials is desirable.

Please send CV to claire.helliwell@hays.com

This is 12 month initial contract (3days on site, inscope)