Study Manager - Oncology

Study Manager - Oncology The Study Manager applies project management, communication, and leadership skills to drive the trial's progression in compliance with all regulatory requirements. The main duties focus on the successful and compliant execution of the clinical trial protocol: Operational Planning and Execution: Accountable for the end-to-end performance of assigned protocols. This includes proactive planning, driving, and tracking deliverables, timelines, and results from study startup through closeout. Team Leadership & Coordination: May serve as the Clinical Trial Team (CTT) lead or coordinate local study teams (including CRAs and other local roles), ensuring strong collaboration and high performance. Risk and Issue Management: Leads the team in timeline management, risk identification and mitigation, and issue resolution throughout the study lifecycle. Stakeholder Collaboration: Facilitates and collaborates with key internal and external stakeholders, such as the study team, country teams, functional vendors, and investigators/sites, to support study objectives. Regulatory Compliance and Quality: Ensures study execution is in compliance with ICH/GCP (Good Clinical Practice) and country-specific regulations, company policies, and quality standards. Study Deliverables: Leads team efforts on key study elements, including: Data management deliverables. Trial-level plans and timelines. Country/site selection. Investigator meeting planning. Communication plans. Study close-out activities. Vendor and Partner Management: Manages any study-specific partners and/or vendors.