Innovation Contracts Manager

About The Organisation

Here at NHS Lanarkshire, we put the patient at the heart of everything we do. Each colleague within the organisation plays a key role in how we deliver our healthcare services.

We proudly serve a population of 655,000 across rural and urban communities in both North and South Lanarkshire. NHS Lanarkshire is comprised of Acute Services (which currently provide hospital based services over 3 main sites), Corporate & Property & Support Services, North and South Lanarkshire Health and Social Care Partnerships which provide integrated primary healthcare and social care services to local communities and surrounding areas.

The remit of this post is to cover a portfolio of Innovation projects across NHS Lanarkshire (NHSL), Typically, innovation projects are developed in collaboration with industry, and the post holder will provide expert advice to Digital/ Diagnostic/ Global Pharmaceutical/ Medical Device Companies and NHS investigators who want to undertake innovation projects within NHSL Health Board. This post is required to set up contracts and manage regulatory and governance approvals for innovation projects.

Given the current strength in informatics, a strong focus will initially be on data and information governance as well as security compliance documentation. However as these innovations translate into new products, this post will also be required to support CE marking through the Medicines & Healthcare Regulatory Authority and any associated clinical investigations.

The post will also deal with procurement both in term of selection of suppliers for innovation projects and input to procurement of systems for full implementation across the region. The post holder will be actively involved in grant costs, providing expert advice in relation to study design, governance and required regulatory approvals.

The NHS Lanarkshire (NHSL) Innovation Contracts Manager works within the parameters set by the NHSL Research & Innovation Committee but is responsible for deciding the most appropriate way to negotiate a contract and makes decisions on the finances required.

A specialised lead in negotiating contracts and reviewing innovation project plans, the post holder is the main point of contact for industry, and grant award bodies wishing to undertake a study involving NHSL systems/ patients.

The post holder is responsible for reviewing and interpreting complex clinical information, across a range of clinical diseases and services. The post holder will negotiate with the innovation teams and support departments to ensure that NHSL has the capabilities & resources to undertake the work and will identify the costs needed to fully support this activity.

Contract negotiation forms a significant part of the remit of this post, and this ensures that full cost recovery to the NHS for resources use. Each innovation project requires the post holder to review and negotiate a study-specific contract that ensures confidentiality and legal regulations are adhered to and that contract provisions are in line with governing law of the host institution.

The post holder is also responsible for making sure that indemnity and compensation arrangements are in place for each innovation project and thus ensuring that the patients, innovators and the Board are fully protected. Additional provisions and indemnities are required for studies that involve medical devices.

As a senior member the RIAP Service the post holder will be involved in the development of Standard Operating Procedures (SOPs) for their work and the staff they work with. These documents require regular review and amendment to comply with changes in local procedures, compliance with regulatory requirements and national initiatives.

The post holder requires knowledge of and works within the bounds of legislation such as :

• General Data Protection Regulations 2018
• EU Medical Device Regulation 2017 (full implementation 2020)
• EU Clinical Trial Regulation 2001/20/EC

and informs and guides investigators through this legislation, If, and when required, the post holder will be actively involved in staff training (Line…