Head of Clinical Operations
Department: Operations
Employment Type: Permanent
Location: Richmond Pharmacology HQ
Description
Job Title: Head of Clinical Operations
Location: London Bridge, SE1
Term: Permanent, Full-time
Salary: Competitive + Benefits (Private Medical, Private Dental, Life Assurance, Private Pension & many more)
The Head of Clinical Operations holds overall accountability for the effective functioning and strategic oversight of the Clinical Operations department. This includes monitoring departmental performance, managing resourcing, ensuring the team is capable and motivated, ensuring efficient and effective processes, maintaining effective documentation, proactively addressing issues, and ensuring appropriate escalation when necessary.
Working in close collaboration with fellow operational Heads of Department, the role is key to optimising study delivery processes while minimising operational burden.
Main duties and responsibilities
Leadership & Line Management
- Initiate and lead regular Clinical Operations department meetings..
- Provide direct line management for Clinical Operations Assistants (COAs) and Clinical Operations Managers (COMs).
- Support COMs and COAs with the management of Clinical Trial Assistants (CTAs) and Ward Supervisors (WSs).
- Handle Non-Conformances (NCs), including investigations and CAPA approvals.
- Conduct annual self-inspections of the department.
- Plan and manage the resources and recruitment for the Clinical Operations team.
- Ensure all staff within the department have clear goals, regular feedback, and appraisals.
- Lead staff development initiatives, including Personal Development Plans (PDPs).
Study Start-Up
- Review Clinical Study Protocols (CSPs).
- Engage in central lab setup discussions, when applicable.
- Attend and contribute to Site Initiation Visits (SIVs).
- Implement and monitor study-specific clinical risk mitigations.
Operational Oversight
- Maintain and update departmental SOPs and Work Instructions (WIs).
- Develop and maintain departmental process maps.
- Drive continuous process improvement initiatives.
- Monitor and report departmental Key Performance Indicators (KPIs) via dashboards and tools to improve performance.
- Participate in the 24-hour on-call rota.
- Oversee daily ward operations and delegate procedures accordingly.
- Conduct spot quality control of ward activities.
- Coordinate and conduct procedure support for executive and director-level activities.
- Lead health and safety for the department, including fire drill procedures and reporting.
- Monitor the budgeted vs. actual time utilisation across the department.
Ongoing Study Support
- Oversee 'intensive day' clinical observations and escalating study-specific queries.
- Participate in audit interviews and address findings.
- Respond to essential monitor (EM) and data management (DM) queries.
Learning & Development
- Conduct COA/COM clinical examinations.
- Conduct internal departmental assessments and exams.
- Manage the development and application of the department’s capability matrix.
- Evaluate staff competencies using MCQs, practical exams, and observational assessments.
- Design and maintain onboarding and training programs across all levels of staff.
Clinical Oversight & Vendor Engagement
- Coordinate vendor training sessions for study-specific procedures.
- Design and review dosing flowcharts in collaboration with cross-functional teams (Clinical Project Management, Pharmacy, Research Physicians).
- Review Master Trial Schedules (MTS).
- Complete Operational Risk Assessments for studies.
- Conduct Time & Motion studies to assess and resolve inefficiencies.
- Host unit tours for CRAs in collaboration with the Clinical Research Coordinator (CRC).
Qualifications and Experience
- BSc or above in Life Sciences or related area
- Previous experience managing a clinical operations function
- Proficient in managing clinical systems and dashboards for operational tracking and KPI reporting
- Proven track record of managing cross-functional clinical teams and delivering high-quality clinical results
- Skilled in solving problems, especially relating to people and a clinical setting
- Adept in recruiting, training and developing people
- Adept at setting and using metrics to drive performance
- Experienced in managing change, ranging from behavioural, clinical, structural, and technological
- Experience in capability assessment, staff training, and clinical competency programs
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Head of Clinical Operations employer: Richmond Pharmacology
Richmond Pharmacology is an exceptional employer, offering a dynamic and supportive work environment for Research Physicians at our London Bridge location. With a strong emphasis on professional development, employees benefit from comprehensive training in clinical trial management, data analysis, and opportunities for publications and teaching, all while collaborating with a diverse, international client base.
