Project Manager
CurrentContractor for Merck & Co. as a Study Manager supporting their Oncology portfolioOperational point of contact for trial execution and all trial deliverablesManages all HQ Operational Activities, including: Establishes, leads and manages Clinical Trial Team (CTT) Supports clinical (drug/vaccine) supplies planningManages deployment and interactions with external vendors (e.g., IVRS, PRO)Initiates planning for Investigator meeting and protocol training.Plans and assesses protocol ancillary suppliesSchedules, prepares for, and leads the Recruitment Planning Meeting for the CTTInitiates recruitment/retention planning & enrollment trackingResponsible for tracking study related details (e.g., specimens, queries)Oversees protocol training activities including IMs and CRAs training meetingsResponsible for operational deliverables in preparation for site ready, country allocation and achievement of recruitment targets (with input from others)Point of escalation for study related operational issuesSets up and maintains Trial Master File (eTMF)Ensures alignment of budget with protocol needsResponsible for risk assessment, mitigation planning and executionResponsible for creating and maintaining ADI logsDevelops Site Monitoring Plan (SMP) with input from the monitoring excellence groupDevelops study related manuals (e.g., administrative binder, lab manuals)Approves contracts, invoice payments and change orders for vendors, as necessaryResponsible for end of study reconciliation (clinical & ancillary supplies)Oversees all HQ close-out tasksResponsible for ongoing monitoring of trial activities, e.g. dashboards, trackingSupports CS activities as needed to achieve CTT deliverablesEDC and DM interface is core function of SMResponsible for quality control and inspection readiness at all times