Senior Clinical Trial Operations Manager

Accountabilities • Serve as the primary operational contact for assigned industry-sponsored clinical trials and projects, overseeing delivery, quality, timelines, scope, and contractual commitments from initiation through closeout.

• Collaborate with research operations leadership and endpoint and specialty services teams to improve project execution, resolve issues proactively, and strengthen organizational efficiency.

• Mentor and guide Clinical Operations Managers and other team members, providing direction on project management practices, deliverables, performance expectations, and quality standards.

• Oversee clinical trial site management activities, including site identification and activation, contract and budget negotiations, monitoring, regulatory documentation, Institutional Review Board (IRB) submissions, and site compliance.

• Coordinate with Clinical Research Associates (CRAs) on monitoring reports, follow-up communications, enrollment tracking, site issues, and corrective actions.

• Manage project scope, budgets, schedules, resources, site payments, vendor relationships, and contracts for services such as investigational product supply, electronic data capture, interactive response systems, core laboratories, and other clinical trial services.

• Provide expert input into the development and review of essential study documents, including protocols, informed consent templates, monitoring plans, project management plans, case report forms, statistical analysis plans, and study reports.

• Support study database development, testing, data entry, data cleaning, documentation management, and investigational product or device tracking, as required.

• Oversee endpoint and specialty services deliverables, including external committee coordination, meeting materials and minutes, serious adverse event (SAE) processes, safety plans, and the handling and review of clinical endpoint documentation.

• Monitor the receipt, quality, processing, and tracking of photographs, acetate tracings, source documents, and other study materials; coordinate follow-up with research sites to resolve missing or inaccurate information.

• Identify and implement process improvements, contribute to standard operating procedures (SOPs), coordinate project-specific training, and ensure adherence to applicable regulations, guidelines, policies, and work instructions.

• Identify, escalate, document, and track project risks and issues through resolution, communicating status updates and recommendations to sponsors, leadership, and relevant stakeholders.

• Support business development through budget development, proposal preparation, benchmarking, change orders, and service agreements; ensure stakeholders understand changes affecting project scope, finances, or resources.

• Coordinate investigator meetings and support the establishment and maintenance of complete Trial Master Files and project documentation.

• Supervise and evaluate direct reports where applicable, provide performance feedback, and undertake additional responsibilities as needed.

Requirements

• A nursing degree, a bachelor's degree in a scientific field, or equivalent knowledge and experience.

• At least five years of experience in a clinical research setting.

• At least three years of experience managing clinical research projects or clinical operations within a sponsor or Contract Research Organization (CRO) environment.

• Demonstrated ability to manage clinical trials across their lifecycle and mentor or oversee other Clinical Operations Managers.

• Thorough knowledge of Good Clinical Practice (GCP) guidelines and applicable FDA and International Council for Harmonisation (ICH) regulations for clinical drug trials.

• Experience coordinating clinical trial sites, vendors, regulatory documentation, project budgets, timelines, and multidisciplinary teams.

• Strong organizational and communication skills, with excellent attention to detail and the ability to manage multiple priorities effectively.

• Proven leadership skills, including the ability to guide staff, encourage collaboration, resolve conflicts, and promote shared accountability.

• Strong problem-solving skills and the ability to adapt quickly to changing project needs while proactively identifying and addressing operational risks.

• Proficiency in Microsoft Office, particularly Outlook, Word, and Excel.

• Willingness and ability to travel approximately 20–25% of the time.

• Successful completion of required background and education verification checks.

Benefits

• Annual salary: $100,000–$140,000, depending on qualifications and experience.

• Remote work: Flexible and remote work schedules.

• Comprehensive insurance: Medical, dental, vision, life insurance, short-term disability, and long-term disability coverage.

• Retirement savings: Dollar-for-dollar 401(k) matching on eligible compensation up to 4%, with immediate vesting.

• Paid holidays: 11 paid holidays annually.

• Paid vacation: 15–25 vacation days, depending on years of service.

• Paid sick leave: Accrual of 2.67 hours every two weeks, up to a maximum of 80 hours.

• Employment type: Full-time.

• Work environment: An opportunity to contribute to clinical research programs while collaborating with multidisciplinary teams in a flexible working environment.

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