Clinical Study Manager

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

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 reports to a Director or higher-level position. The position requires excellent written and verbal communication, project management skills, 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.

Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables. In a CRO outsourcing model, responsibilities also include:

• Study Oversight:
  Lead the clinical study operational aspects of planning, execution, and management of one or more Phase 1-3 clinical trials. May provide support as back-up to the Study Delivery Lead as needed.
• Cross-Functional Leadership:
  Participate and provide expertise as a cross-functional study team member, including vendors, and liaise with other departments. Provide mentorship of more junior Operations team members.
• Vendor Management:
  Lead vendor selection, contracting, and management to maintain study quality and compliance and adherence to scope of work within timelines and budget. Oversee complex vendors (e.g., eCOA).
• CRO Oversight:
  Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level. Coordinate and develop materials for CRO KOMs and Investigator meetings.
• Compliance and Regulatory:
  Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.).
• Timeline and Budget Management:
  Create and coordinate clinical study timelines and budgets with Global Project Management and R&D Finance to meet critical milestones and manage budgets. Responsible for continual review of study timelines and study budget.
• Risk Management:
  
  Identify, mitigate, and elevate risks per process throughout the study lifecycle. Ensure risks are appropriately logged in the risk management system.
• Study Material Development:
  Co-develop and manage study materials, including training materials, protocols, CRFs, and study operational plans. Ensure all necessary operational materials are in place.
• Data Cleaning:
  Oversee site and monitor data cleaning metrics including EDC data entry, query resolution timeliness, and protocol deviation review.
• Site Management:
  Oversee site selection, start-up, monitoring, and closeout for the trial.
• Study Communication:
  Triage, resolve or elevate study issues/risk mitigations to the Study Delivery Lead.
• Support all inspection readiness and quality initiatives pertaining to assigned studies.
• Supports risk management initiatives.
• Supports audit/inspection activities as needed.
• Ensures trial master file is complete and accurate for assigned studies.
• Communication and Reporting:
  Provide regular updates on study progress to key stakeholders.
• Training:
  Identify training needs for key stakeholders as needed, e.g., study team members, vendors and ensure training is carried out. Develop training materials as necessary.