Clinical Trial Management Associate

The Clinical Trial Management Associate (CTMA) is a key member of the Clinical Operations team and will partner closely with the Clinical Trial Manager (CTM), Senior CTM, and Associate Director, Clinical Operations. The CTMA will support the execution of a global Phase 3 program, with a primary focus on study coordination, documentation, and operational support. Under the supervision of the Associate Director, Clinical Operations or the Senior CTM, the CTMA may manage sites within a region (e.g., EMEA or Americas) and/or vendors (e.g., IRT, eCOA, etc.) Key responsibilities: Provide operational and administrative support for day-to-day clinical trial activities, including study start-up, maintenance, and close-out. Support site start-up activities, including tracking of site start-up components and assisting with site activation readiness. Accountable for study level tracking at Sponsor (e.g., monitoring visit tracking, sample tracking, patient tracking, site activation tracking, etc.) Act as a point of contact for CROs and study sites for routine communications and follow-ups, including escalations and engagement. Assist with coordination of investigator meetings and study-related communications. Track study timelines, deliverables, and key milestones; proactively follow up on outstanding items. Maintain internal Clinical Operations systems, trackers, and document repositories. Prepare and distribute study status updates and meeting minutes and ensure vendors do the same. Assist with vendor coordination and oversight, including vendor set-up, performance, and deliverable tracking. May assist with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations. Support review of study documents (e.g., informed consent forms, regulatory packages) and route for approval. Maintain and QC the Trial Master File (TMF) and ensure documents are filed in a timely and compliant manner; create, maintain, and close out TMFs; play a central role in setup, conduct, and close out of ancillary services; facilitate quality reviews and support trending activities. Facilitate and/or assist in review of CRO monitoring trip reports for completeness and consistency and, under supervision of other Operations personnel, may complete co-monitoring activities. Track protocol deviations and support trending activities. Support data review activities, including tracking queries and assisting with data listings review. Perform administrative duties in a timely manner as assigned. Adhere to Clinical Operations processes and SOPs.