.Global Clinical Operations (GCO)ED&CP Site Manager I*(*Title may vary based on Region or Country requirements)Position Summary:A Site Manager I in Early Development & Clinical Pharmacology (ED&CP) serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of early development and/or clinical pharmacology studies. A Site Manager I is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out. Partners with the Clinical Trial Assistant (CTA), Trial Manager (TM) and Global Trial Leader (GTL) to ensure overall site management while performing trial related activities for assigned protocols.A Site Manager I may contribute to process improvement and training.Principal Responsibilities:1 Participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team2 Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution.3 Attends/participates in investigator meetings as needed.4 Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies.5 Ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at sites and sponsor level.6 Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.7 Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.8 In collaboration with Site Investigational Product Specialist (SIPS) and Pharmacy Investigational Product Specialist (PIPS), ensures that clinical drug supplies are appropriately handled, administered and stored. Ensure strict adherence to investigational product preparation and administration guidelines. Ensures clinical drug supplies are appropriately inventoried, accounted and returned as applicable including maintenance of accurate and complete documentation.9 Ensures site staff complete the data entry and resolve queries within expected timelines. Set up plan to improve data entry in collaboration with TM when needed
