Senior Associate Study Manager

Responsibilities:

• Must meet all requirements for Clinical Trial Management Associate position and have demonstrated proficiency in all relevant areas.
• 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
• May be asked to assist in the training of Clinical Trial Management Associates and Clinical Project Assistants.

Requirements:

• 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.
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
• Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision as required.

Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice. By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.