King's College London

About us

King’s Health Partners Clinical Trials Office (KHP-CTO) brings together the globally renowned university King’s College London and three leading NHS Foundation Trusts to deliver high-quality clinical trials that drive better care.

The Commercial team at the King’s Health Partners Clinical Trials Office (KHP-CTO) delivers streamlined, expert support for industry-sponsored clinical trials across our Partner Trusts: Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, and South London and Maudsley NHS Foundation Trust.

About the role

The Commercial Trials Associate is part of a busy team providing an efficient and effective study set-up service for investigators, companies and contract research organisations that are engaging in commercial clinical research within the partner organisations. 

The Commercial Trials Associate will work closely with our research teams and collaborators and act as a single point of contact for the duration of study set up. The post holder will work with the team to review and negotiate commercial trial budgets and contracts in accordance with the National Contract Value Review process including studies where we are the lead site. They will lead on assessing, arranging and confirming local capacity and capability of new trials where we are the local site in accordance with the NIHR 150-day metric. The post holder will also be responsible for the line management of one direct report.

Key Responsibilities:

• To act as a single point of contact for a large and diverse portfolio of commercial clinical trials in set up across the Partner Organisations.
• To lead on assessing, arranging and confirming local capacity and capability of new commercial trials where we are both lead and local site in accordance with the National Contract Value Review process and NIHR 150-day metric.
• To lead on setting up new commercial trials, including the review and negotiation of contractual and financial terms in accordance with the National Contract Value Review process and NIHR 150-day metric and ensure accurate completion.
• Responsible for providing an effective, high quality, timely and efficient contractual and financial/budgetary service to investigators, companies and contract research organisations seeking to conduct commercial trials in any of the Partner Organisations.
• Lead the delivery of the NIHR 150-day study set-up metric by proactively progressing study approvals, escalating delays and maintaining accurate milestone tracking data.
• To review and negotiate commercial trial budgets for contract amendments in accordance the National Contract Value Review process. To review and negotiate ad hoc agreements where needed, including CI Agreements, PIC Agreements and SLAs and ensure accurate completion.
• The ensure the set-up and administration of Commercial trials is in compliance with the relevant legal, regulatory and internal governance.
• To provide day to day line management of one direct report including 1:1 meetings, conducting annual PDR’s and all aspects of performance management and associated activities. The post holder will also mentor and develop new and existing team members.
• To work closely with academic, clinical and other staff, at all levels and across the partner organisations, providing appropriate advice and developing effective working relationships to help grow clinical research activity.
• To work closely with contract research organisations and commercial sponsors.
• To maintain the records of the clinical trials portfolios of the partner organisations including the EDGE system and ensuring information added is quality checked.
• To ensure that trials metrics are collected and data is entered in a timely fashion, to permit tracking of milestones by updating shared trackers.
• To act as an ambassador for KHP-CTO.
• To maintain a working knowledge of prevailing regulations, guidance, best practices and GCP standards regarding the conduct of clinical trials. To ensure confidentiality of commercially sensitive information and that data protection imperatives are respected.
• To actively contribute to the wider KHP-CTO team, working flexibly and proactively.

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.

This is a full-time (35 hours per week) post, and you will be offered a fixed term 12-month contract.

About you

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria 

1.      Experience of leading the set-up, administration or delivery of commercial clinical trials within the NHS or pharmaceutical industry environment.

2.      Knowledge and understanding of the relevant contract templates and commercial costing model under the National Contract Value Review process and NIHR 150-day metric.

3.      Educated to degree level or possess equivalent relevant experience in clinical trials.

4.      Excellent organisational and time management skills with the ability to manage competing priorities and tight deadlines under a large and diverse portfolio of trials. A self-starter who can work largely unsupervised within a target-driven environment.

5.      Proficient negotiator with ability to influence and excellent written and verbal communication skills. Demonstrably high levels of accuracy and attention to detail.

6.      Excellent interpersonal and stakeholder engagement skills. Tactful and being able to deal with a wide range of people in an enthusiastic and helpful manner and the ability to build successful relationships.

7.      Practical problem-solving skills and the ability to think analytically and flexibly whilst being capable of firmly maintaining policies and regulations.

8.      Knowledge, understanding and experience of the legal, regulatory, and statutory governance of clinical trials. Including GCP.

9.      Proficient in Microsoft Office applications, particularly Excel, and experience using databases, web-based systems or trackers to maintain accurate records and monitor performance metrics.

10.    Experience of line management.

Desirable criteria

1.      Demonstrates a commitment to a quality culture with a professional demeanour and high ethical standards

2.      Familiar with NIHR guidelines around clinical trial set-up timelines within the NHS. 

Downloading a copy of our Job Description 

Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the page. This document will provide information of what criteria will be assessed at each stage of the recruitment process.

Further Information

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.

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.

We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the person specification section of the job description. If we receive a strong field of candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.

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 here.

We reserve the right to close adverts early due to the volume of applications we receive. While the closing date may change, all adverts will close at 23:59 to allow sufficient time for applications to be submitted on that day.

We encourage you to apply at the earliest opportunity to avoid disappointment as once we have closed a vacancy you will be unable to submit your application.

To find out how our managers will review your application, please take a look at our ‘How we Recruit’ pages.