Global Study Manager - Oncology and/or Multi TA

Job title: Global Study Manager - Oncology and/or Multi TA

About the Role Global Study Managers (GSMs) provide operational leadership across the full clinical study lifecycle, with accountability for the oversight and delivery of study management, site management, and vendor activities. In this role, you will lead global clinical trials from sourcing strategy and RFP development through study start-up, execution, database release, and inspection readiness—ensuring timely delivery of high-quality data. As a key member of the core study team, you will represent the operational function, drive recruitment strategies and milestone delivery, and partner cross-functionally to align operational plans with overall study objectives.

What You'll Do

• Form, oversee and lead the operational sub-team and allocate resources as needed.
• Develop realistic detailed startup and/or study management strategies and monitoring plans, including Sourcing Strategy, input into RFPs, and for the selection of vendors.
• Ensure country-level feasibility is completed in collaboration with cross functional GSSO colleagues and OAQS, and pCRO (as applicable) reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans.
• PTMF setup for Study management and Country/Site level documents; inputs into IQMP risk planning.
• Coordinate development of study/protocol training and global investigator meetings; ensure local Investigator meetings are coordinated by the Study Operational Manager (if assigned).
• Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs) and ensure budgeting inputs from Study Operational Managers (local tasks).
• Monitor budget and contracts for assigned vendors (e.g., central labs, ePRO, radiology, pCRO, etc.); review cost variance, invoices, POs to ensure spend is on forecast.
• Responsible for delivering the study against approved plans; leads inspection readiness activities related to study management and site readiness.
• Support development and delivery of decentralized capabilities at investigator sites.
• Post-database lock responsibilities include timely study closure and release of resources.
• Develop, review or approve Study Startup, Study Monitoring & protocol recruitment plans and related documents; may delegate.
• Approves & oversees drug supply management; manages flow of drug supply to the sites and sets up Interactive Randomization Systems with Supply Chain Lead.
• Ensure vendor oversight for vendors managed by Study Operational Managers; escalate issues as needed; review Pre-trial assessments and feasibility outputs with cross functional teams.
• May support study level submission readiness; may participate in vendor UAT and system setup reviews (IRT, Central Lab).
• Ensure system closure at study completion; lead study startup and monitoring functions to ensure compliance with SOPs and Quality Standards.
• Interface with data management and GSSO to ensure data flow and timely delivery; regularly review data reports to identify risks and drive mitigations.
• Review plan deviations with Clinical Study Team Lead and drive mitigations.
• May lead routine study management vendor calls.
• Serve as the technical expert for study management systems and processes; champion harmonized processes and cost-efficient deliverables.

What We're Looking For

• Strong leadership and independent work style; ability to manage cross-functional teams and external partners.
• Experience leading global clinical trials across oncology or multiple therapeutic areas; end-to-end study lifecycle management.
• Proven ability in study startup, site/feasibility assessments, vendor management, budget and contract oversight, and inspection readiness.
• Familiarity with data management, IRT/central lab systems, and study management tools.
• Strong communication, collaboration, and problem-solving skills; ability to mentor and drive continuous improvement.