Clinical Trial Manager

King's College London; City of Westminster; Sur place; GBP 70 000 - 110 000; Plein temps

Résumé du poste

King’s College London is seeking a Senior Clinical Trial Manager to provide strategic and operational leadership for a major international sepsis research programme. You will drive trial delivery across the UK and abroad, establish robust processes, governance and partnerships, and oversee ethics, regulatory approvals and data management.

You will lead site feasibility, set-up, training and ongoing support, while monitoring recruitment, budgets and delivery risks.

Qualifications

• Minimum level 6 qualification in a relevant subject, plus substantial work experience managing laboratory operations, biological sample processing or biobanking within a research-intensive environment.
• Experience establishing, expanding or transforming laboratory, technical or research infrastructure services.
• Experience developing and implementing Standard Operations Procedures, quality systems and laboratory governance frameworks.
• Experience developing technical specifications, business cases and procurement plans for major scientific equipment and laboratory infrastructure.
• Solutions-focused self-starter with excellent analytical, planning, and organisational skills, experienced in leading technical teams and supporting researchers in a complex scientific environment.
• Comprehensive knowledge and experience of managing complex facilities, including laboratory compliance, risk management and health and safety in biological research environments.
• Experience working effectively with multidisciplinary stakeholders including researchers, clinicians, technical staff, professional services teams and external suppliers.

Responsabilités

• Lead study set-up and trial delivery, developing operational plans and recruitment strategies.
• Coordinate ethics, regulatory and governance approvals and maintain essential documentation.
• Oversee data quality, query resolution and study reporting, including use of study databases and electronic data capture systems.
• Provide guidance and support to trial management and coordination staff across sites, ensuring timely delivery and risk mitigation.

Connaissances

Lab operations management

Biobanking experience

SOPs & quality systems

Procurement planning

Leadership of technical teams

Regulatory compliance & safety

Stakeholder collaboration

Formation

Bachelor’s degree or higher in a relevant field

Description du poste

This is a rare opportunity to play a leading role in mobilising and delivering one of the largest international sepsis research programmes ever undertaken. As our Senior Clinical Trial Manager, you will provide strategic and operational leadership across the programme's clinical trial and research delivery activities, building the processes, partnerships and infrastructure that will drive a complex, multi-site research programme across the UK and internationally. If you are an experienced clinical trial leader who thrives on turning ambitious plans into real-world impact, we would love to hear from you.

About the role

We are seeking a Senior Clinical Trial Manager to provide strategic and operational leadership for the mobilisation and delivery of a major international research programme. You will help establish the processes, partnerships and infrastructure needed to deliver complex, multi-site clinical studies across the UK and internationally. Reporting to the Director of the Centre for Critical Illness Research, you will work closely with the Programme Lead, Head of Programme, investigators, NHS partners and research delivery teams. You will lead study set-up and trial delivery, developing operational plans, timelines, recruitment strategies and standard operating procedures, while coordinating study meetings, reporting and the escalation of issues. You will coordinate ethics, regulatory and governance approvals, maintain Trial Master Files and essential documentation, and ensure studies comply with Good Clinical Practice, sponsor requirements and approved protocols. You will lead site feasibility, initiation, training and ongoing support, monitor recruitment, follow-up and site performance, and identify and mitigate risks to delivery. The role also includes oversight of data quality, query resolution and study reporting, supporting the implementation and effective use of study databases and electronic data capture systems. You will coordinate dependencies across consent, sampling, follow-up, contracts and site approvals, support monitoring of resources, budgets and site payments, and provide guidance and support to trial management and coordination staff. Throughout, you will maintain effective partnerships and uphold data governance and confidentiality requirements. This role is full time, 35 hours per week, offered on an open-ended contract and is funded until 31 January 2033, in the first instance.

The Equality Act of 2010 protects the rights of our students and staff and provides a framework to fulfil our duties to eliminate unlawful discrimination, harassment and victimisation and in addition, to advance equality of opportunity and foster good relations between those who share a protected characteristic and those who do not. At times, this will include balancing rights and beliefs that can feel in tension. We are committed to free speech and to academic freedom, believing that our foundational purpose as a university, is to create spaces where a wide range of ideas, including ideas that are controversial, can be discussed and debated, and where members of our community can express lawful views without fear of intimidation, harassment or discrimination. When engaging in the robust exchange of ideas, we ask that our community is mindful of our Dignity at King's guidance.

Artificial intelligence (AI) is evolving rapidly, and we recognise its growing role in professional work. Applicants may use AI tools to support preparation of their application, for example to research the role or structure written responses. However, applications must reflect the applicant's own work and experience. AI tools should not be used during interviews or assessment activities unless this has been agreed in advance as a reasonable adjustment. Further guidance on the use of AI in recruitment can be found .

Essential criteria

• Minimum level 6 qualification in a relevant subject, such as an undergraduate or postgraduate degree, plus substantial work experience managing laboratory operations, biological sample processing or biobanking within a research-intensive environment management posts or Extensive work experience in relevant technical/ scientific posts with a managerial experience/ or qualification. .
• Experience establishing, expanding or transforming laboratory, technical or research infrastructure services.
• Experience developing and implementing Standard Operations Procedures, quality systems and laboratory governance frameworks.
• Experience developing technical specifications, business cases and procurement plans for major scientific equipment and laboratory infrastructure.
• Solutions-focused self-starter, with excellent analytical, planning, and organisational skills experienced in leading technical teams and and supporting researchers in a complex scientific environment .
• Comprehensive knowledge and experience of managing complex facilities, including laboratory compliance, risk management and health and safety in biological research environments.
• Experience working effectively with multidisciplinary stakeholders including researchers, clinicians, technical staff, professional services teams and external suppliers.

Desirable criteria

• Experience working effectively with multidisciplinary stakeholders including researchers, clinicians, technical staff, professional services teams and external suppliers.
• Experience supporting large-scale cohort studies, translational research programmes or clinical research infrastructure.
• Experience supporting large-scale cohort studies, translational research programmes or clinical research infrastructure.
• Experience of laboratory accreditation and quality management systems

Join us at the forefront of critical illness research. The (CCIR) is a leading interdisciplinary research centre that unites academics, clinicians and professional services colleagues around a shared mission: to translate early scientific breakthroughs into effective prevention, diagnosis and treatment strategies for critically ill children and adults.

At King’s, we believe that the diversity of our community and a culture that is welcoming, open, inclusive and collaborative, are great strengths of the university.