Senior Associate Clinical Study Lead Job Description:
- 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 (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to Gilead 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, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures under close supervision.
- May be asked to assist in the training of Clinical Trial Management Associates and Clinical Project Assistants.
- Typically requires a BSc or BA in a relevant scientific discipline or RN qualification or international equivalent.
- 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.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
Senior Associate Clinical Study Lead, Senior Associate Clinical Project Manager, Senior Associate Trial Manager, Clinical Trial Manager, Clinical Project Manager, Clinical Study Manager, Clinical Study Lead
Aerotek® is a leading provider of technical, professional and industrial recruiting and staffing services. We do not provide engineering services directly but specialise in locating and placing qualified engineers with customers who are seeking their skills. Aerotek is a division of Allegis Group Limited, a wholly owned subsidiary of Allegis Group® Inc., the fourth largest staffing company in the world. Allegis Group Ltd is an Employment Business and Agency. Aerotek operates a network of more than 150 non-franchised offices, employing 2,000 recruiters to identify, screen and select top talent.
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