Associate Director, Clinical Operations

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

Summary:

Responsible for the planning and implementation of clinical operations deliverables, primarily site management and clinical monitoring of assigned projects to ensure delivery within specified budgets and timelines, in accordance with applicable regulatory guidelines/requirements, Tempus Compass Standard Operating Procedures (SOPs), and project-specific instructions. Manages and contributes to continuous process and quality improvement within the Clinical Operations department.

Independently serves as Clinical Trial Lead and/or Strategic Oversight (as assigned) on complex studies, applying and providing guidance to clients and team members on best practices tailored to the applicable project, patient population, investigational product, and client. Responsible for coaching/mentoring and supporting the CRA team and representing the clinical operations function to the client. Expected to build positive rapport with internal and external project teams and site staff.

Serves in a line management and leadership role with minimal supervision and guidance.

Job Responsibilities:

Tasks may include but are not limited to:
Lead/Perform independently, with minimal guidance and oversight:

Clinical Trial Lead Responsibilities:

• Manage clinical operations deliverables, including timeline, quality, scope, and financials.
• Develop plans, monitor resource allocation, and ensure clinical site management and monitoring are delivered with quality and efficiency.
• Proactively identify risks and escalate to the Project Manager and other appropriate functional leads.
• Together with the Project Manager, ensure transparent communication internally and externally regarding study progress and issues.
• Contribute to Risk, Action, Issue, and Decision (RAID) tracker, including the Risk Assessment Categorization Tool (RACT).
• Anticipate client needs and proactively resolve issues as necessary.
• Develop and maintain project-specific clinical operations plans (e.g., Clinical Monitoring Plan, Cohort Management Plan, Recruitment Plan).
• Develop and maintain project-specific clinical operations reference materials and tools, including study-specific forms and logs.
• Develop training materials and conduct training for the clinical operations team throughout the project lifecycle.
• Provide operational oversight for site and CRA deliverables and key performance indicators such as site activation, subject recruitment, site monitoring visits, data currency, and quality.
• Manage CRA resourcing, site assignments, visit schedules, and serve as the initial point of contact for clinical operations and monitoring issues.
• Review and approve site monitoring visit reports; monitor and track related metrics for compliance with the Clinical Monitoring Plan and Tempus Compass SOPs.
• Conduct monitoring visits, co-monitoring visits, assessment visits, and/or team training as necessary.
• Support inspection-ready Trial Master File (TMF) for the duration of projects; perform maintenance tasks such as filing and periodic quality reviews of clinical operations documents, and prepare for audits and archiving.
• Maintain project-related data in the Clinical Trial Management System (CTMS), project-specific SharePoint sites, and/or other tracking spreadsheets as applicable.
• Support the creation of the Investigator Site Files (ISF) and/or Site Reference Manual as applicable.
• Coordinate the distribution of clinical trial materials and ensure inventory is adequate for the overall study.
• Assist Regulatory Affairs and Investigation Services (RAIS) with secondary review and QC of essential documents such as the Informed Consent or Clinical Trial Agreement.
• Assist the Project Manager with processing of clinical investigator payments and other financial items as required.
• Perform other duties as assigned.
• May involve overnight travel.

Clinical Operations Department Responsibilities:

• Provide strategic oversight for assigned projects or portfolios.
• Line-manage Clinical Operations personnel, including interviewing, selection, terminations, professional development, and performance appraisals.
• Contribute to management of department-level metrics, quality, and risks.