- Facilitates 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 (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to Gilead SOPs and protocol procedures
* Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
* Review of trip reports generated by CRO and CRAs.
* Communicates and collaborates with other functional groups
* Facilitates the Management of the CRO's and vendor's as required.
* Prepares and organises international investigator meetings
* Assists in preparation of safety, interim and final study reports.
Knowledge and Skills
* Educated to degree level or equivalent in a scientific discipline
* Previous experience of pharmaceutical clinical trial experience
* CRA experience is highly desired
* Oncology experience is 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.
If you are having difficulty in applying or if you have any questions, please contact Matthew Pike at 02074400639
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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