Head of Operations & Business Management

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.

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. Document Management / Trial Master File

Site Monitoring & Oversight

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

Act as the primary escalation point for project-related issues within assigned responsibilities.

Stakeholder Engagement & Continuous Improvement

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.

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.

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.

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.

Proven experience in process development and improvement initiatives.

Strong planning, organizational, analytical, and problem-solving skills.

Experience in direct line management.

Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).

Willingness to travel as required.

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.

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.

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.

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.

Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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.

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