Senior Clinical Trial Operations Manager
New
J
JobgetherClinical research
Based in the United StatesFull-TimeManager
Salary100,000 - 140,000 USD per year
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Job Details
- 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.
- Required Skills
- Microsoft Office
Requirements
- Hold a nursing degree, a bachelor's degree in a scientific field, or have equivalent knowledge and experience.
- Have at least five years of experience in a clinical research setting.
- Have at least three years of experience managing clinical research projects or clinical operations within a sponsor or CRO environment.
- Demonstrate experience managing clinical trials across their lifecycle.
- Demonstrate ability to mentor or oversee other Clinical Operations Managers.
- Have thorough knowledge of Good Clinical Practice (GCP) guidelines and applicable FDA and ICH regulations for clinical drug trials.
- Have experience coordinating clinical trial sites, vendors, regulatory documentation, project budgets, timelines, and multidisciplinary teams.
- Be proficient in Microsoft Office, particularly Outlook, Word, and Excel.
- Bring strong organization, attention to detail, and ability to manage multiple priorities.
- Demonstrate leadership, collaboration, conflict resolution, and shared-accountability skills.
- Have problem-solving skills and ability to adapt to changing project needs and address operational risks.
- Be willing and able to travel approximately 20–25% of the time.
Responsibilities
- Serve as the primary operational contact for assigned industry-sponsored trials and projects from initiation through closeout.
- Oversee trial delivery, quality, timelines, scope, contractual commitments, budgets, schedules, resources, site payments, vendors, and service contracts.
- Collaborate with research operations leadership and endpoint and specialty services teams to improve project execution and resolve issues.
- Mentor and guide Clinical Operations Managers and other team members on project management practices, deliverables, and quality standards.
- Oversee site identification and activation, contract and budget negotiations, monitoring, regulatory documentation, IRB submissions, and site compliance.
- Coordinate with CRAs on monitoring reports, follow-up communications, enrollment tracking, site issues, and corrective actions.
- Provide input on study documents, including protocols, informed consent templates, monitoring plans, case report forms, statistical analysis plans, and study reports.
- Oversee endpoint and specialty services deliverables, including committee coordination, SAE processes, safety plans, and clinical endpoint documentation.
- Identify, document, escalate, and track project risks and issues, communicating status and recommendations to sponsors, leadership, and stakeholders.
- Support process improvements, SOPs, project-specific training, business development, investigator meetings, and Trial Master File maintenance.
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