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.

Job Summary

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.

Job Description

Responsibilities

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 (i.e., 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 escalate 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 escalate study issues /risk mitigations to the Study Delivery Lead.

• Support all inspection readiness and quality initiatives pertaining to assigned stud(ies).).
  oSupports risk Management initiatives
  oSupports audit/inspection activities as needed
  oEnsures trial master file is complete and accurate for assigned stud(ies)

• 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.

Responsibilities Continued

Qualifications

Education Qualifications
Bachelor's Degree preferred in Life Sciences required

Experience Qualifications
3 or more years required and
Relevant experience is required with a BSc required and
Experience in oversight of global clinical trials (all phases) in all stages of delivery with requisite industry training and experience required and
Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). preferred
CRA experience preferred
Time spent directly in a medical environment (e.g. as a Study Site Coordinator) preferred
Familiarity to a Japan-based organization preferred

Travel Requirements
Ability to travel up to 10% of the time. In-house office position that may require occasional travel (domestic or global).

Additional Information

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range:

USD$133,600.00 - USD$200,400.00