Clinical Operations Manager

A position has arisen for a Clinical Operations Manager to join our company. The role purpose is to lead the Group’s clinical research programme and play a key strategic role in the business by actively contributing to the development of new products through the generation of high-quality clinical evidence.

Your responsibilities will include:

Strategic Leadership & Cross-Functional Collaboration

• Act as the strategic lead for clinical operations, bridging Clinical Affairs with Product Research to support innovation and evidence generation for new product development.
• Partner with Product Research and Regulatory teams to shape clinical evidence strategies that inform product design, claims, and market access.
• Provide strategic oversight for legacy products, ensuring robust Post-Market Clinical Follow-up (PMCF) and lifecycle clinical evidence generation.

Clinical Programme Oversight

• Manage the company's clinical research programme across medicines, medical devices, and cosmetics, ensuring compliance with ISO 14155, Medical Device Regulation (MDR), Good Clinical Practice (GCP), and other applicable requirements.
• Oversee planning, execution, and reporting of clinical investigations, observational studies, and PMCF activities.
• Maintain oversight of all study documentation, approvals, monitoring, and audits.

Governance & Compliance

• Ensure adherence to regulatory and ethical requirements across all clinical activities, proactively monitoring and interpreting changes in legislation.
• Perform gap analyses in collaboration with QA, ensuring business readiness and compliance.
• Support safety evaluation and reporting processes in liaison with Pharmacovigilance (PVG).
• Maintain deputy archivist responsibilities for GCP compliance and study archiving.

External Partnerships & Vendor Management

• Build and maintain strong professional relationships with CROs, academic partners, and other external stakeholders.
• Ensure contracts and insurance arrangements are in place with third-party service providers.
• Oversee vendor performance and ensure alignment with company standards and regulatory obligations.

Team Management, Training & Capability Development

• Effectively manage and develop the team to ensure successful delivery of the Group’s clinical research programme.
• Ensure appropriate training for staff involved in clinical studies, fostering a culture of quality and compliance.
• Mentor and coach team members to develop functional capability within Clinical Affairs and provide guidance on best practices in clinical operations.

Person Specification:

Qualifications and Education

• Degree in life sciences, pharmacy, biomedical sciences, clinical research, or a related discipline.
• Evidence of continued professional development in clinical, regulatory or operational disciplines.

Knowledge and Experience

• Significant experience in clinical operations, or clinical research management within the medical device, pharmaceutical, or related healthcare sector.
• Demonstrable understanding of clinical development pathways for medical devices, including PMCF and lifecycle management.
• Strong working knowledge of GCP, ISO 14155, EU MDR, UK MDR, and related international standards and guidelines.
• Experience in managing both interventional and non-interventional clinical studies, including oversight of study start-up, monitoring, data management, and reporting.
• Proven track record in vendor and stakeholder management, including Clinical Research Organisations (CROs), academic / clinical partners, and other third-party providers.
• Familiarity with pharmacovigilance principles and the integration of safety reporting within clinical study programmes.
• Experience in preparing or contributing to study reports, scientific papers, regulatory submissions and technical documentation (e.g., Clinical Evaluation Reports).
• Knowledge of quality management systems (ISO 13485) and their application to clinical research activities.
• Strong project management skills, including budget oversight, timeline management, and resource planning.
• Competence in the use of clinical study management tools, databases, and Microsoft Office applications.

Skills and Attributes

• Strategic outlook: ability to translate business objectives into clinical evidence strategies.
• Strong analytical and problem-solving ability, with the capacity to identify issues early and implement effective solutions.
• Highly organised and detail-oriented, with excellent planning and documentation skills.
• Clear and confident communicator, capable of influencing at all levels and building strong cross-functional relationships.
• Leadership capability, with experience mentoring or coaching team members and fostering a culture of quality and compliance.
• Adaptable and resilient, able to work effectively in a fast-paced, evolving environment with competing priorities.
• Ethical and integrity-driven, with a strong commitment to compliance, patient safety, and professional standards.
• Self-motivated and proactive, able to work both independently and as part of a multidisciplinary team.