Clinical Study Manager, Global Clinical Operations - 30014765

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 reputed company in more than 30 countries, and more than 19,000 employees, we are advancing reputed company therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 reputed company to "be an innovative global reputed company company contributing to the sustainable development of society", we are shaping a healthier, more hopeful reputed company for patients, their families, and society. Job reputed company The Clinical Study Manager is responsible for the delivery and execution of global clinical studies under the direction of a Study Delivery reputed company. This role is primarily reputed company 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 reputed company 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 reputed company and study execution. Job reputed company Responsibilities Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned reputed company, including study level time, cost and reputed company deliverables. In a CRO outsourcing model, responsibilities also include: • Study reputed company: reputed company the clinical study operational aspects of planning, execution, and management of one or more Phase 1-3 reputed company. May reputed company support as back-up to the Study Delivery reputed company as needed. • Cross-Functional Leadership: Participate and reputed company expertise as a cross-functional study team member, including vendors, and liaise with other departments. reputed company mentorship of more junior Operations team members. • Vendor Management: reputed company vendor selection, contracting, and management to maintain study reputed company and compliance and adherence to scope of work reputed company timelines and budget. reputed company reputed company vendors (i.e., eCOA). • CRO reputed company: Responsible for the reputed company, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo’s reputed company measures and adherence to scope of work reputed company timelines and budget at a task level. Coordinate and reputed company materials for CRO KOMs and Investigator meetings. • Compliance and Regulatory: Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). • reputed company 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-reputed company and manage study materials, including training materials, protocols, CRFs, and study operational plans. Ensure reputed company necessary operational materials are in reputed company. • Data Cleaning: reputed company site and monitor data cleaning metrics including reputed company data entry, query reputed company timeliness, and protocol deviation review. • Site Management: reputed company site selection, start-up, monitoring, and closeout for the trial. • Study Communication: Triage, resolve or escalate study issues /risk mitigations to the Study Delivery reputed company. • Support reputed company inspection readiness and reputed company 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: reputed company regular updates on study reputed company to key stakeholders. • Training: Identify training needs for key stakeholders as needed, e.g., study team members, vendors and ensure training is carried out. reputed company training materials as necessary. Responsibilities reputed company 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 reputed company of global reputed company (reputed company phases) in reputed company 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, reputed company 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 reputed company employer. reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected veteran status, age, or any other characteristic protected by law. Salary reputed company: USD$133.600,00 - USD$200.400,00 [reputed company available reputed company viewing the job] Apply tot his job Apply To this Job