Senior Manager, Clinical Technical Operations

Job Summary:The Senior Manager, Clinical Technical Operations within Clinical Operations is responsible for supporting the implementation, integration, and optimization of technical systems and processes that support the planning, execution, and oversight of clinical trials. This role bridges the gap between clinical operations and technical functions, ensuring that digital tools, platforms, and data systems are effectively leveraged to drive operational efficiency, compliance, and data integrity. The Senior Manager will collaborate cross-functionally with Clinical, Data Management, IT, Quality, and external vendors to support system implementation, process automation, and continuous improvement initiatives. This role also includes oversight of technical service providers and may involve line management responsibilities.Key Responsibilities:Technical Systems Oversight - Support the implementation, configuration, and maintenance of clinical operations systems (e.g., CTMS, eTMF, EDC, eCOA, IRT). Serve as a subject matter expert (SME) for clinical systems, ensuring alignment with regulatory requirements, operational needs, and data governance standards. Oversee system integrations in accordance with organizational architecture and compliance frameworks. Manage implementation of data transfers between internal systems and external vendor platforms, ensuring data accuracy, consistency, and compliance with applicable regulations. Lead the development and maintenance of data flow diagrams and technical documentation to support system architecture transparency, audit readiness, and cross-functional understanding. Champion data stewardship by promoting best practices in data quality, ownership, lifecycle management, and ensuring that clinical data is managed as a strategic asset across the organization. Collaborate with IT and system vendors to troubleshoot issues, manage upgrades, and ensure system validation and compliance. Process Optimization & Automation - Identify opportunities to streamline clinical management activities through technology and process automation. Lead initiatives to enhance workflow efficiency, data accuracy, and system interoperability. Develop and maintain SOPs, work instructions, and training materials related to technical systems and processes. Cross-Functional Collaboration - Partner with Clinical Management, IT, Data Management, and other applicable functions to align technical solutions with business objectives. Support cross-functional teams in the implementation, testing, adoption and effective use of clinical systems and tools. Support development of user training, onboarding, and change management for new technologies and processes to ensure successful system adoption. Vendor & Service Provider Management Oversee technical service providers and vendors supporting clinical systems and tools. Participate in vendor selection, contract negotiations, and performance monitoring. Ensure vendors meet service level agreements (SLAs), compliance standards, and project timelines. Data Governance & Compliance Ensure data integrity, security, and compliance with GCP, ICH, 21 CFR Part 11, and other applicable regulations. Support audits and inspections by providing system documentation, access logs, and validation records, as applicable. Collaborate with applicable business stakeholders, QA, and IT to maintain audit readiness and implement corrective actions as needed. Performance Monitoring & Reporting Define and track key performance indicators (KPIs) related to system usage, data quality, and operational efficiency. Generate reports and dashboards to support decision-making and continuous improvement. Present technical findings and recommendations to leadership and cross-functional stakeholders. People Management (as applicable) Provide leadership, coaching, and development for direct reports. Oversee workload allocation, performance management, and professional growth of team members. Foster a culture of accountability, innovation, and continuous learning. Qualifications:Required: Bachelor's degree in life sciences, information systems, or a related field (advanced degree preferred). Minimum of 6 years of experience in clinical operations, technical operations, or clinical systems management within the pharmaceutical or biotech industry. Strong understanding of clinical trial processes and regulatory requirements (e.g., GCP, ICH, 21 CFR Part 11). Experience with clinical systems such as CTMS, eTMF, EDC, IRT, eCOA, etc. Proven track record in system implementation, process improvement, and vendor management. Experience designing and managing data flow diagrams and overseeing data transfers between systems. Excellent analytical, project management, and communication skills. Ability to work independently and cross-functionally to manage multiple priorities in a fast-paced environment. Experience in line management or team leadership is a plus. Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint). Willingness to travel as required. CompetenciesAccountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.Empowered Development - Play an active role in professional development as a business imperative.Minimum $134,615.00 - Maximum $201,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.Application Deadline : This will be posted for a minimum of 5 business days.Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.Come discover more about Otsuka and our benefit offerings; .Disclaimer:This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. 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 gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request () .Statement Regarding Job Recruiting Fraud ScamsAt Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. 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Created: 2026-03-08