WHAT DOES A CLINICAL OPERATIONS MANAGER DO?
Updated: Dec 10, 2024 - The Clinical Operations Manager implements and monitors assigned clinical trials, ensuring adherence to timelines, budgets, and quality standards while maintaining strict compliance with ICH/GCP and internal SOPs. This role involves overseeing interactions with internal functions, CROs, vendors, and trial sites, acting as the main point of contact, and ensuring the sponsor’s oversight responsibilities are met. The manager also regularly reports trial status, escalates urgent issues, and manages financial results, identifies and corrects inefficiencies while conducting quality control and safety evaluations.
A Review of Professional Skills and Functions for Clinical Operations Manager
1. Clinical Operations Manager Roles
- Quality Accountability: Holding the team accountable for quality and Key Performance Metrics
- Training and Leadership: Devising training and coaching and leading a varied team of CRAs, CTAs, In-house CRAs, and Start-up Specialists
- Client Exposure: Exposure to all types of clients: Global Pharma companies, BioTechs, and local clients
- Internal Collaboration: Rich interaction with internal client partners (Unit Heads, Pharmacovigilance, Regulatory, Medical Affairs…)
- Retention Strategies: Implementing creative retention strategies, keeping the team motivated and committed
- Process Ownership: Owning processes and information required to execute and support the clinical trial including clinical trial project plan, project timelines, resourcing, budget plans, and statements of work
- Document Preparation: Accountable for the preparation and finalization of key clinical documents which include the clinical protocol, informed consent, case report form, and other essential study documents
- Study Management: Managing study conduct, ensuring that operating procedures and company policies are followed and that trials meet all applicable regulations and guidelines required to gain approval for JJV medical devices
- CRO Selection and Oversight: Responsible for the selection of Contract Resource Organizations (CRO) and oversight of contracts, timelines, and budgets
- Process Improvement: Managing and improving clinical trial processes, including benchmarking and leveraging across other J and J companies
- Client Communication: Participating in weekly client status calls to discuss progress and issues
2. Clinical Operations Manager Tasks
- Program Leadership: Provides program leadership and operational strategy for one or more molecules
- Operational Strategy: Creates operational strategy for Clinical Development Plans (CDP)
- Clinical Operations Planning: Accountable for clinical operations planning and implementation of clinical development program including scenario planning, forecasting of timelines
- Resource and Budget Estimation: Accountable for assessment of program-level feasibility, estimation of resources and budget, and development of operational strategies
- Team Leadership: Leads program-level clinical operations team and collaborates with cross-functional team members
- Strategic Input: Provides leadership and strategic input to all partnered molecules
- Vendor Management: Participates in the identification and selection of clinical operations vendors
- Performance Management: Manages direct reports including performance management planning for team members
- Department Strategy: Contributes to developing department strategy and processes to ensure adherence to Denali's standards and all applicable regulations and guidelines
- Budget Forecasting: Contributes to the development and maintenance of the necessary resources and budget forecasting for Clinical Operations at the department level
- GCP Compliance: Contributes and facilitates Clinical Operations' GCP compliance activities, reporting, and inspection readiness systems and activities
- Inspection Preparation: Oversees clinical site and sponsor GCP inspection preparation and support activities
3. Clinical Operations Manager Overview
- Operational Support: Support the development and delivery of a new clinical service, with a focus on the operational, governance, and financial performance of the service.
- SOP Development: Develop standard operating procedures for the clinical service.
- Governance Implementation: Support the CMO in developing and implementing governance processes within Koa to ensure that there is a comprehensive framework to continuously monitor and improve the quality of care provided.
- Quality and Governance Support: Provide advice and support to staff in respect of quality and governance issues.
- Performance and Quality Standards: Establish clinical and non-clinical performance and quality standards and ensure that systems are in place to regularly monitor and evaluate these.
- Remedial Action: Take appropriate remedial action when performance and quality standards are not as expected.
- Financial Management: Take accountability for the effective financial management of services within the area of responsibility, ensuring that they are delivered within agreed financial plans and budgets.
- Workforce Planning: Lead workforce planning, including recruitment, induction, appraisal, and training of the clinical team.
- Skill Matching: Ensure that staff with the right skills are in the right roles and that the workforce adapts to meet the needs of service users.
- Professional Leadership: Provide professional leadership and to ensure staff are appropriately skilled and trained to deliver the service.
- Clinical Record Keeping: Ensure that the highest standards of clinical record keeping including electronic data entry and recording, report writing, and the responsible exercise of professional self-governance by professional codes of practice and Koa policies and procedures are followed by all staff.
- Budget Oversight: Oversee study budget(s) and review/approve invoices.
- GCP Adherence: Adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs.
4. Clinical Operations Manager Functions
- Biomarker Logistics: Oversee biomarkers (including PK, PD, prognostic and predictive markers) sample logistics, vendor, and data management.
- Sample Tracking: Track the collection and shipment of clinical samples from the clinical site to biobanks or 3rd party laboratories for testing.
- Collaboration: Work closely with Clinical Operations, CROs, and Translational Medicine to ensure all samples are collected, shipped, and received according to schedule.
- Issue Resolution: Work closely with Clinical Operations, CROs, and/or clinical sites to resolve sample-related issues promptly.
- Sample Retrieval: Manage retrieval of samples from tissue repositories/participating centers.
- Coordination: Coordinate sample logistics and data transfers with Diagnostic Development partners.
- Kit and Data Management: Manage kit preparation, sample collection procedures, shipping requirements, and data collection/reporting.
- Documentation Verification: Ensure and verify that collaborators have appropriate documentation, processes, and procedures in place to ensure appropriate sample collection.
- Data Transfer Specifications: Develop and update current data transfer specifications by gathering input from biomarker leads, data management, and data scientists to ensure consistent data transfers.
- Vendor Management: Ensure vendors keep to the schedule of data transfers and the data format is consistent with internal infrastructure.
- Program Understanding: Have a clear understanding of the programs’ clinical biomarker plan, which enables the review of laboratory manuals, informed consent, analytical plans, and SOWs.
- Study File Review: Ensure review of study files (the protocol and any amendments, ICFs for sample/tissue collection, correspondence with the IRB, and other study-related documents).
5. Clinical Operations Manager Job Summary
- Clinical Trial Management: Implement, monitor, supervise, and direct the assigned Clinical Trial(s).
- Timeline and Budget Compliance: Ensure all trial deliverables are met according to timelines, budget, operational procedures, and quality / GCP standards.
- TMF Oversight: Oversee and maintain Trial Master File (TMF) in strict compliance with ICH/GCP and internal Standard Operating Procedures (SOPs).
- Team Coordination: Streamline interactions with relevant internal functions by leading and coordinating the Clinical Team.
- Vendor and Site Liaison: Act as the main point of contact with CRO, vendors, and trial sites to ensure the sponsor’s oversight responsibilities.
- Issue Reporting: Regular reporting of important trial issues, status, and progress of the trial, timely escalating any (urgent) issues.
- Outsourcing Management: Develop clinical outsourcing specifications to facilitate bid templates and selection of clinical research vendors.
- Quality Reporting: Understand quality initiatives and reporting programs, including the ability to design and produce outcomes reports that incorporate internal and external quality metrics.
- Financial Oversight: Oversee financial results related to assigned programs, ensuring revenues and expenses meet the budget.
- Process Improvement: Identify and correct problems and inefficiencies in processes, materials, equipment, or skills.
- Quality Control and Safety: Conduct quality control and safety evaluations for assigned units.
- Training: Provide training to new Client Services and Operations Specialists.