Senior Manager, Clinical Operations

We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.

Position Summary

This position is responsible for management of the Clinical Monitoring department and individual Clinical Research Associates (CRAs) to ensure research trials are completed in compliance with the protocol, GCP, FDA regulations, ICH guidelines, and overall clinical objectives.

Essential Functions

• Ensure staff are properly qualified and trained by developing training and onboarding plans, providing input to CRA training materials, and overseeing the CRA training program.
• Participate in monthly utilization preparation and review by accurately reporting productivity metrics and completing utilization trackers.
• Identify and escalate issues as appropriate within the organization.
• Directly manage a team of CRAs to ensure monitoring duties are completed in compliance with the protocol, GCP, FDA regulations, ICH guidelines, and overall clinical objectives.
• Immediately report any clinical trial fraud, misconduct, or serious breaches to the TD2 PM and TD2 senior management.
• Review trial contracts and budgets, providing input to ensure accurate scope and budgeting.
• Participate in monthly revenue recognition activities by accurately reporting completed work and completing appropriate revenue trackers and/or systems.
• Participate in bid defense and Sponsor meetings as requested.
• Ensure that CRAs verify that the safety and rights of trial patients are protected, patient enrollment eligibility is confirmed, and consent for enrollment is properly obtained and documented prior to patient participant on a clinical trial.
• Collaborate with Sponsors, Vendors, and TD2 departments (e.g., Project Management, Data Management, Biostatistics and Programming, Medical Monitoring, Finance, and Business Development) to successful complete clinical trial responsibilities.
• Perform other related duties as assigned.
• Maintain accuracy of TD2 controlled documents related to clinical monitoring and ensure CRA compliance with TD2 controlled documents and training, ensuring staff adhere to controlled document requirements.
• Measure performance for assigned CRAs, including conducting periodic surveys to assess CRA performance at clinical trial sites and performing quality control visits (co-monitoring and/or accompanied field visits).
• Perform resource management activities to ensure CRAs are assigned to clinical trials in time to meet trial needs.
• Review and approve CRA travel expenses and invoices, ensuring compliance with internal guidelines and timeframes.
• Maintain a fully staffed department by sourcing, selecting, and onboarding and training CRA staff
• Ensure quality and timely submission of site visit letters and monitoring visit reports.
• Create and manage department timelines with proactive timeline communication.
• Maintain template of department forms and plans related to monitoring (e.g., Clinical Monitoring Plan, monitoring visit report and letter templates, visit report guidelines)
• Compile and provide metrics related to department performance (e.g., on-time visit reports, confirmation letters, follow-up letters, adherence to the Clinical Monitoring Plan).
• Effectively communicate with senior management on strategies to grow the Clinical Monitoring business at TD2, including forecasting and predicting future department needs regarding resources, technology, and training.

Job Requirements

• Minimum two (2) years of experience in the field of oncology.
• Minimum eight (8) years of experience in a pharmaceutical/biotech/CRO industry with progressive experience working on clinical trials.
• Minimum four (4) years of relevant experience directly managing staff in a health care setting, including management of CRAs.
• Minimum of five (5) years of experience as a CRA.
• Bachelor’s degree required, preferably in a life science field. Nursing or medical qualifications or relevant clinical research experience in a pharmaceutical/biotech/CRO industry may be considered.

Required Specialized/Technical Skills

• Overall knowledge of GCP, ICH, and FDA regulatory requirements governing human clinical trials, with detailed knowledge related to clinical monitoring.
• Excellent technical writing skills.
• Deep understanding of the principles of clinical monitoring and ability to lead and manage a clinical monitoring team.
• Proven experience working in cross-functional project teams.
• Experience with Microsoft Office tools and applicable business software.
• Expected 25% overnight travel dependent for accompanied field visits, CRA training, and clinical trial workload
• Proven ability to exercise independent judgment and use critical thinking to analyze problems which may require multiple factors and approaches.
• Excellent verbal and written communication with strong interpersonal skills.

TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.