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Responsibilities:

• Lead the development of the clinical study plan including critical path activities and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent.
• Lead the creation of the cross functional Clinical Study Oversight Plan (CSOP) under the guidance of the study team leader and take a leadership role in ensuring study team adherence to the CSOP and manage the overall implementation and documentation of the CSOP including activities conducted by CROs and vendors.
• Provide operational input into study protocol profiles, final protocols and amendment.
• Lead document review & coordination for the protocol and amendments.
• Additional medical writing tasks may involve ICF, CRF guidelines, and IB and safety communications.
• Lead the CRO and vendor selection process in collaboration with the study team and outsourcing procurement management.
• Lead the creation of the CRO scope of work in collaboration with Outsourcing Procurement Management. CRO, 3rd Party Vendor Management and Oversight:
• Responsible for the oversight, performance and management of CROs and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work within timelines and budget at a task level.
• Specifically track operational study timelines and monitor operational performance metrics through the life of the study; Identify issues and propose solutions.
• Responsible for ensuring that the Clinical CRO(s) provide timely input and generate documents in a timely manner and with quality (e.g. communication plan, site monitoring plan, etc) as per study plan.
• Coordinate with the CRO to prepare and execute meetings including Vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings and training.
• Note that vendor management is not limited to the CRO, but includes 3rd party vendors (e.g. translations, trial insurance, and central laboratory, etc).
• Review CRO-generated reports such as monitoring visit reports, protocol deviation reports, and analysis of site metric reports.
• Identify areas of concern and either resolve, propose solutions, or bring to the attention of the operations lead of study team lead. Coordinate and liaise with Daiichi Sankyo QA on site audit and inspection activities.
• Conduct and/or oversee the CRO oversight monitoring visits (CROOM visits) as outlined in the CSOP.

Requirement:

• 5-6 years' relevant experience required with a BSc.
• Experience in clinical operations methods and processes in industry setting required.
• 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). CRA experience is preferred, Clinical Project Management skills are required. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant.
• Familiarity to a Japan-based organization is desirable.
• Demonstrates high-level knowledge of design and phases of clinical studies, global regulatory issues, CRO operations, and compliance practices Interacts appropriately with high levels of internal and external stakeholders (e.g., CROs); focuses on developing and building strong relationships Demonstrates appropriate level of understanding and application of internal and external compliance practices and global regulatory bodies and inspections Demonstrates ability to manage and present all points of the clinical project, particularly complex projects Supports and effectively multi-tasks different and complex assignments and responsibilities Investigates and determines solutions to difficult, problematic situations; escalates issues as necessary.
• Effectively manages and leads study teams within the matrix of the organization; provides coaching and training Sound understanding of the concepts and applications of clinical research, medical terminology and other disciplines involved in drug development. Proficiency in computer applications such as Microsoft Word, Excel, Microsoft project timeline and PowerPoint. Strong oral and written communication skills.