Clinical Study Manager

Job Summary Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and management of Otsuka clinical studies, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution, and completion of clinical trials according to applicable regulations and guidance, ICH Guidelines Good Clinical Practices (GCP), and Otsuka SOPs, within agreed‑upon timeframes and budgets. Responsibilities Provide oversight and management of clinical studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations, guidance, ICH/GCP, and Otsuka SOPs. Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed consent forms, and other study‑related documents. Provide input into and approval of the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS), and investigative sites. Provide leadership and guidance to the clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance. Communicate and coordinate clinical project‑related activities and progress across all relevant cross‑functional departments. Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required. Participate in forecasting study expenditures and resourcing needs. Ensure internal clinical team and vendors manage and monitor study‑related budget and expenses to meet forecast. Provide timely communication of any variances in budget forecast to the Director/Associate Director. Establish communication flow with CRO and investigative sites to maximize compliance with study protocol. Provide oversight of ESP in its day‑to‑day operations of assigned trial(s), as assigned. Participate in ongoing review of clinical trial data focusing on data integrity, trending, and consistency. Support project‑level inspection readiness activities, including responsibility for ensuring the completeness, timeliness, and quality of the TMF. Serve as Clinical Management representative for review of protocols within and across portfolios, as assigned. Participate in program‑level risk mitigation strategies and collaborate with ESPs on study‑level risk mitigation and management activities. Represent Clinical Management in departmental and cross‑functional initiatives, as assigned. Lead and/or contribute to assigned departmental, ESP, and corporate standardization and continuous improvement efforts. May have supervisory responsibilities, including coordinating training and onboarding of new employees, ensuring compliance with departmental SOPs and corporate training, setting performance expectations, and providing feedback. Perform other duties as assigned. Qualifications Comprehensive knowledge of clinical operations, drug development process, and GCP/ICH regulations. Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of vendor statements of work. Strong understanding of the clinical and scientific basis for assigned clinical programs, with ability to translate that knowledge into operational management. Strong understanding of global regulatory requirements. Strong communication, organization, planning, analytical, problem‑solving, and people‑management skills. Demonstrated experience with Microsoft Office (Word, Excel, PowerPoint, Outlook). Good understanding of clinical trial related software (eCRFs, IRT, CTMS). Ability to travel up to 25%. Bachelor’s Degree or Registered Nurse (RN) with minimum 10 years industry experience, including seven years in clinical trial management. Previous supervisory experience (preferred). Compensation and Benefits Salary range: $150,034.00 – $224,250.00 (US) with incentive opportunity. Benefits include comprehensive medical, dental, vision, prescription drug coverage; life, accidental death & dismemberment, short‑term and long‑term disability insurance; tuition reimbursement; student loan assistance; generous 401(k) match; flexible time off; paid holidays; paid leave; and other company‑provided benefits. EEO Statement Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. Qualified individuals with a disability or a disabled veteran may request reasonable accommodation if required. #J-18808-Ljbffr