Head of Clinical Operations

Job Title: Head of Clinical Operations

Location: London Bridge, SE1

Term: Full-Time, Permanent

Salary: Competitive + Benefits (Private Medical, Private Dental, Pension, 25 days Annual leave plus bank holidays & Many more)

Richmond Pharmacology are an early phase Clinical Research Organisation (CRO), where we are conducting pioneering early phase healthy participants and patient participant trials. Our experienced and world-renowned team, our central London location and our global reach contribute to making Richmond Pharmacology an exciting and dynamic place to work.

The Role:

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, 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.

Key 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. You will also 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 escalate 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).

Skills and Experience:

• BSc or above in Life Sciences or related area
• Extensive experience in clinical operations within a CRO, pharma, or clinical trials unit.
• Proven track record of managing cross-functional clinical teams and delivering high-quality clinical studies.
• In-depth understanding of ICH-GCP, MHRA regulations, and clinical trial processes.
• Strong leadership, interpersonal, and communication skills.
• Proficient in clinical systems and dashboards for operational tracking and KPI reporting.
• Experience in capability assessment, staff training, and clinical competency programs.

Application:

If you are interested in the role, please register your details, including a copy of your CV. Please note, while we try to respond to every candidate, the high volume of applications anticipated may make this impossible and we ask for your patience and understanding.
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