• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports. • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. • Updates, tracks and maintains study specific trial management tools/systems, and status reports. • Manages site start up procedures including feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities. • Assists in the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee. • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. • Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits. • Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote). • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs. • Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations. • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. • Reconciles contents of the ISF with the Trial Master File (TMF). • Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management. • Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image. • Performs investigational product (IP) inventory, reconciliation and reviews storage and security. • Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies. • Identifies and processes Serious Adverse Events according to the procedures defined by the study team.