Global Clinical Operations (GCO) Senior Site Manager Position Summary: A Senior Site Manager is a mid-level site management role with typically 3-5 years of experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. A Senior Site Manager is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring, and close-out activities. The Senior Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and TDL (Trial Delivery Leader) to ensure overall site management while performing trial-related activities for assigned protocols. A Senior Site Manager may contribute to process improvement, training, and mentoring of other Site Managers. A Senior Site Manager is generally expected to operate independently with little or limited supervision.
Principal Responsibilities: Acts as the primary local company contact for assigned sites for specific trials. May participate in site feasibility and/or Site Qualification Visit. Attends/participates in investigator meetings as needed, may be expected to help prepare meeting materials and may be required to present at the IM. Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study-specific systems and other reports/dashboards), and site/study close-out according to SOPs, Work Instructions (WIs), and policies. Responsible for the implementation of an analytical risk-based monitoring model at the site level and to work with the site to ensure timely resolution of issues found during monitoring visits. Able to implement and execute all tasks independently with little or limited supervision. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during the site activation phase in order to speed up the process and activate the site in the shortest possible timeframe. May be required to help provide solutions to challenges faced in other sites in the country. Contributes to site-level recruitment strategy and contingency planning and implementation in partnership with other functional areas. Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct. Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and documented.
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