Clinical Operations Lead Manager - Early Phase Studies

Job Summary Otsuka invites you to take on a vital leadership role as a Clinical Operations Lead Manager for Early Phase Studies. In this exciting position, you will be responsible for overseeing early-phase clinical studies while collaborating closely with the Director and Associate Director of Clinical Management. Your expertise will ensure that studies are executed efficiently, within compliance of rigorous regulations, ICH/GCP guidelines, and internal SOPs, all within defined timelines and budgets. Responsibilities Provide expert oversight of clinical studies, ensuring full compliance with all relevant regulations and quality standards. Play a critical role in the creation and review of essential clinical study documentation, including protocols and informed consent forms. Lead the process of assessing and selecting CROs and external vendors, ensuring strict adherence to vendor contracts. Guide the clinical team in maintaining operational protocols and timelines for project success. Facilitate open and effective communication regarding study progress across various cross-functional teams. Regularly update management on project scope, timelines, and resource allocation. Watch forecast and monitor study expenditures, ensuring budget compliance and timely communication of any variances. Establish strong communication channels with CROs and investigative sites to enhance protocol compliance. Oversee the daily operations of assigned clinical trials, collaborating with external service providers effectively. Review clinical data to ensure integrity and consistency. Support inspection readiness by maintaining a high-quality, complete Trial Master File (TMF). Actively contribute to the development of risk mitigation strategies at both program and study levels. Engage in departmental and corporate improvement initiatives aiming at standardization and continuous improvement. Potentially supervise a team, coordinating training and ensuring full compliance with policies and procedures. Qualifications/Required Knowledge/Experience and Skills: In-depth knowledge of clinical operations, drug development processes, and ICH/GCP regulations. Comprehensive understanding of CRO and vendor management. Strong grasp of global regulatory requirements for clinical studies. Exceptional skills in communication, organization, analysis, and interpersonal relations. Proficiency in Microsoft Office Suite and clinical trial management software. Willingness to travel up to 25% as needed. Educational Qualifications Required: Bachelor's Degree or equivalent experience as a Registered Nurse (RN) with a minimum of 10 years in the industry, including at least 7 years of clinical trial management experience. Preferred: Prior supervisory experience is a valuable asset. Competencies Accountability for Results: Focus on achieving strategic objectives with high performance. Strategic Thinking & Problem Solving: Make decisions benefiting customers, patients, and the organization in the long term. Patient & Customer Centricity: Prioritize the needs of customers and stakeholders. Impactful Communication: Communicate effectively and respectfully at all levels to achieve positive outcomes. Respectful Collaboration: Embrace diverse perspectives while working towards common goals. Empowered Development: Commit to personal and professional growth as a core value. Salary range: $150,034.00 - $224,250.00, with incentives; actual pay will be based on experience and skills. Company Benefits: Otsuka offers comprehensive medical, dental, and vision coverage, a 401(k) match, flexible time off, and more. This job description outlines the key responsibilities and qualifications for the position. Otsuka reserves the right to amend and change responsibilities as necessary. Otsuka is an equal opportunity employer. All applicants will be considered irrespective of race, color, sex, gender identity, or other legally protected characteristics. For individuals with disabilities or veterans needing accommodations, please contact Accommodation Request. Security and Recruiting Fraud Statement: Otsuka does not request personal financial information during the hiring process. Only utilize official Otsuka channels for job-related communications.

Created: 2026-03-11