The Manager, Trial Operations is responsible for the development, oversight, and execution of assigned clinical operations activities to support the successful delivery of clinical trials. Reporting to the Senior Manager or Associate Director, the Manager will manage assigned Trial Operations areas while also driving continuous improvement initiatives and cross-functional collaboration to ensure operational excellence and adherence to timelines and quality standards. With a strong focus on performance metrics, stakeholder engagement, and resource optimization, the Manager supports delivery of clinical trial operations activities while ensuring clinical trials associated operational activities are executed efficiently and in alignment with regulatory and organizational standards. This position may also include direct line management responsibilities, fostering team development, and accountability and oversight of external service providers.

Key Responsibilities:

Engagement Delivery & Oversight

• Execute operational processes aligned with internal policies, SOPs, and compliance standards.
• Establish and monitor KPIs and operational metrics to ensure timely, high-quality execution of deliverables.
• Serve as a point of contact for designated operational functions, providing guidance, training, and support to stakeholders and team members to ensure consistent execution and adherence to best practices. Areas of focus may include:
  • Document Management / Trial Master File
  • Site Monitoring & Oversight
  • Supplier Engagement
  • Trial Operations Coordination
  • Clinical Quality & Inspection Readiness
  • Process Management
  • Risk-Based Quality Management (RBQM)
  • Study Startup Operations
  • External Service Provider Management & Oversight

Cross-Functional Collaboration & Escalation Management

• Partner with cross-functional teams to support strategic initiatives and ensure seamless execution.
• Act as the primary escalation point for project-related issues within assigned responsibilities.

Stakeholder Engagement & Continuous Improvement

• Engage proactively with internal and external stakeholders to gather feedback and identify improvement opportunities.
• Support enhancements to workflows, systems, and processes to drive innovation and efficiency.
• Champion a culture of continuous improvement, collaboration, and responsiveness to evolving business and regulatory needs.

Compliance & Quality Assurance

• Ensure all activities are executed in compliance with regulatory requirements, internal standards, and business objectives.
• Foster a culture of quality and compliance across all aspects of assigned responsibilities within Trial Operations.

Project Coordination & Resource Management

• Coordinate and allocate resources to support departmental and ensure successful execution of assigned clinical operations activities.
• Track progress, manage risks, and provide regular updates to leadership and applicable stakeholders.
• Escalate issues as needed to ensure timely resolution.

Oversight of External Service Providers

• Provide operational oversight of external service providers (e.g., CROs/FSPs, consultants, vendors) involved in the execution of applicable operational activities.
• Ensure external partners are aligned with objectives, timelines, and quality standards through regular communication, performance monitoring, and issue resolution.
• Participate in vendor selection, contract negotiation, and scope definition to ensure optimal service delivery and cost-effectiveness.
• Monitor adherence to contractual obligations, KPIs, and regulatory requirements, escalating concerns as needed to ensure compliance and mitigate risk.
• Foster collaborative relationships with external partners to promote transparency, accountability, and continuous improvement in service delivery.

Financial Management

• Provide input in the development and management of clinical operations budgets, ensuring alignment with project scope, timelines, and strategic priorities.
• Monitor expenditures across assigned activities and vendors to ensure cost-effectiveness and adherence to approved budgets.
• Identify opportunities for cost optimization without compromising quality or compliance.
• Collaborate with Finance and Procurement teams to ensure accurate forecasting, timely invoicing, and resolution of financial discrepancies.
• Provide input into vendor contract negotiations and change orders to ensure financial accountability and transparency.
• Maintain financial documentation and reporting in accordance with corporate policies and audit requirements.

Qualifications/Required:

• Bachelor's degree in life sciences or related field preferred.
• Minimum 4+ years of experience in the pharmaceutical/biotechnology industry.
• Strong knowledge of clinical trial processes, regulatory requirements, and industry best practices.
• Experience with clinical study vendors and contracting activities.
• Proven experience in process development and improvement initiatives.
• Ability to work independently and collaboratively in a fast-paced environment.
• Strong planning, organizational, analytical, and problem-solving skills.
• Excellent communication and interpersonal skills.
• Demonstrated leadership and mentoring capabilities.
• Experience in direct line management.
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Willingness to travel as required.

Competencies
Accountability 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 $121,103.00 - Maximum $181,125.00, 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; https://www.otsuka-us.com/careers-join-otsuka.

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.