Overview
Commercial Trials Associate – Strand, London, WC2R 2LS
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.
IMPORTANT: Before applying for this role, please make sure you have the right to work in the country where the role is based. Unless it clearly stipulates within in the job advert above that the hiring company is looking to or able to sponsor applicants it is deemed that the hiring employer will only consider applications from those able to comply with and work in the country where the role is based.
