Clinical Study Manager

Job title: Clinical Study Manager

About the Role The Clinical Study Manager is responsible for the delivery and execution of global clinical studies under the direction of a Study Delivery Lead. This role is primarily focused on tactical study delivery and requires excellent written and verbal communication, project management, and attention to detail. The Clinical Study Manager will have routine interaction with key internal and external stakeholders to communicate project status, resolve issues, and troubleshoot routine inquiries. This position may require the Clinical Study Manager to take on a dual role of both operational strategy and study execution.

What You'll Do

• Lead the clinical study operational aspects of planning, execution, and management of one or more Phase 1-3 clinical trials in a global CRO outsourcing model; may back up the Study Delivery Lead as needed.
• Participate as a cross-functional study team member (vendors and other departments); mentor junior Operations staff.
• Lead vendor selection, contracting, and management to maintain study quality and adherence to scope, timelines, and budget.
• Oversee complex vendors (eCOA) and CRO/third-party vendors to ensure compliance with Daiichi Sankyo quality measures and scope of work; coordinate materials for CRO KOMs and Investigator meetings.
• Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.).
• Create and coordinate clinical study timelines and budgets with Global Project Management and R&D Finance; continually review timelines and budgets.
• Identify, mitigate, and escalate risks; maintain risk logs.
• Co-develop and manage study materials (training materials, protocols, CRFs, operational plans); ensure all necessary operational materials are in place.
• Oversee data cleaning metrics (EDC data entry, query resolution timeliness, protocol deviation review).
• Manage site activities (selection, start-up, monitoring, closeout).
• Triage, resolve or escalate study issues/risk mitigations to the Study Delivery Lead; support inspection readiness and quality initiatives.
• Support risk management initiatives and audit/inspection activities as needed; ensure Trial Master File is complete and accurate for assigned studies.
• Provide regular updates on study progress to key stakeholders; identify training needs and develop materials as necessary.

What We're Looking For

• Bachelor's Degree in Life Sciences required; preferred degree in Life Sciences.
• 3+ years of experience overseeing global clinical trials (all phases) with requisite industry training; BSc required.
• Experience in oversight of global clinical trials across all stages of delivery; familiarity with clinical or basic research in a Pharmaceutical, Medical Device/Diagnostic, ARO, or CRO environment.
• CRA experience preferred; time spent in a medical environment (e.g., Study Site Coordinator) preferred.
• Familiarity with a Japan-based organization preferred.
• Travel up to 10% of the time; in-house office position that may require occasional travel (domestic or global).

Nice to Have

• CRA experience
• Direct experience in a CRO outsourcing model
• Experience with eCOA and complex vendor management

Compensation & Benefits

• Travel requirements up to 10%.
• In-house office position with occasional travel; no salary information provided.