Research Contracts Manager

The post holder will advise research colleagues on the contracting arrangements needed for clinical trials and other research projects, especially research sponsored by Christie. They will provide advice about where contracts are needed to cover the receipt and payment of funding, appropriate human tissue management, protection of personal data and the development and protection of intellectual property.

The role will provide dedicated contract negotiation requiring close liaison with charitable and commercial funding bodies, other NHS organisations, academic institutions and companies engaged in the development of pharmaceutical or other healthcare products. Advances in technology, especially AI, are moving at pace in cancer research and the contracts managers are expected to keep up to date with the opportunities and pitfalls which accompany such advances. Our contracts team is at the heart of research projects to share, exchange and combine personal data for increased patient benefit.

DUTIES AND RESPONSIBILITIES

1. Clinical Trial and Other Research Contracts

Review and negotiate all confidentiality agreements where third parties disclose information to the Trust which may lead to research activity.

Review and negotiate contracts with pharmaceutical companies, academic institutions and other NHS organisations to ensure that the rights of patients and the Trust are protected throughout clinical trials. Clear and comprehensive clauses dealing with funding, data protection and confidentiality, liability and indemnity in particular are essential.

Review and negotiate contracts with third parties to support the Trust in delivering clinical trials, for example, where certain services are required by the trial protocol but are not available at the Trust.

Liaise with research investigators, service support departments and research delivery teams at the Trust to ensure contracting arrangements accurately reflect the rights and responsibilities of the Trust and the other party to the contract.

Liaise with the Income and Costing Team so that the team can complete a comprehensive review of the financial requirements in clinical trial contracts and, in particular, support the team to implement national costing arrangements through contracts.

Take responsibility for the correct use of the trial management system in place at the Trust to ensure effective review and monitoring of trial contracts from first sight through to contract execution.

Liaise with external solicitors to obtain specialist advice on legal and regulatory issues affecting delivery of clinical trials at the Trust. Instruct external solicitors to draft or review contracts for technical matters where legal support is required.

Identify and prepare, using a template wherever possible, the most appropriate contracting arrangements for research projects which sit outside the Trusts clinical trial activity e.g. data sharing with other research organisations.

Initiate and/or participate in structured risk assessments to identify, classify and minimise risk to the Trust arising under clinical trial and other research contracts.

Ensure that investigators, service support departments and research delivery teams are aware of their responsibilities under clinical trial and other research contracts.

Provide training on clinical trial contracts to the research delivery teams so that they understand key contractual characteristics.

Contribute to the design and monitoring of meaningful performance measures to ensure confidence in the trial contract review process.

Participate fully in the formulation and implementation of policies and procedures connected to contracting for research activity at the Trust

2. Christie-Sponsored Trials

Support the Trusts sponsor team and the R&D Solicitor Consultant by reviewing and negotiating the contracts required to deliver clinical trials and other research sponsored by the Trust. Contracts play an essential part in allowing the Trust to maintain oversight of sponsored activity and must cover audit and monitoring as well as clearly defining the obligations of the contracting parties.

3. Communication and relationship skills

build good working relationships quickly with research delivery teams;

possess the communication and interpersonal skills required to negotiate the terms of contracts with third parties; and

positively communicate the Trusts approach to research when dealing with commercial organisations, regulatory bodies, academic institutions and other NHS organisations.

4. Knowledge, training and experience

• keep up to date with and apply changes to current practice;
• maintain knowledge of relevant guidance and good practice;
• attend training and workshops that are related to the role.

5. Analytical skills

The post holder will be required to negotiate in the interests of the Trust based on their understanding and judgement of the necessity and relevance of clauses within contracts.

6. Planning and organisational skills

The post-holder will identify and plan a broad range of complex functions to improve delivery of the dedicated contracts service and/or the processes which the service supports. The post holder will work individually, and in collaboration with colleagues in the R&I Office and across research delivery and service departments as well as with external organisations whose contributions they have identified as being necessary to plan for change.

The Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country. We are also an international leader in research, with world first breakthroughs for over 100 years. We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.

The contracts team is embedded in Christie research in the friendly R&I Office. The team consists of contracts managers who report to the R&I Solicitor Consultant. We meet frequently to find solutions, promote consistency and share updates. Contracts managers have strong relationships with other teams especially those managing sponsored studies, research quality and funding. The primary purpose of the role is to ensure the interests of the Trust are fully protected through effective contracts. The R&I Office is based in the Paterson Building right next to our specialist hospital. This is where Christie, the University of Manchester and Cancer Research UK work together to improve outcomes for all cancer patients.

Essential: - -First degree; - -Knowledge of written contracts gained through experience or relevant post graduate qualification

Desirable: - Legal qualification

Essential: - -Knowledge and experience of preparing, reviewing and negotiating contracts; - -Appreciation of the importance of confidentiality, data protection and the ownership of intellectual property to the parties of a contract; - -Understanding of indemnity and liability clauses

Desirable: - -Experience in research involving patients and/or in the NHS; - -Experience of the application of data protection legislation in practice

Essential: - -Negotiation skills which contribute to success in a range of settings, including evidence of motivation and influencing skills; - -Oral and written communication skills which effectively provide and receive key information when relating to research delivery teams, investigators and other staff; - - Ability to communicate "technical" contractual information in a manner appropriate to the relevant audience; - -Interpersonal skills which support the formation and maintenance of strong working relationships; - -Flexible approach to ways of working should include the ability to work independently and on own initiative where appropriate as well as the ability to work as part of a team and knowledge of when to seek guidance; - -Effective organisational skills including reprioritisation to meet tight and /or unexpected deadlines; - -Evidence of analytical approach to problem solving and careful attention to detail; - -Knowledge of MS Office products relevant to role. Training on the trial management system will be provided if required

Essential: - -Awareness of the applicability of the Medicines for Human Use (Clinical Trials) Regulations, relevant data protection and human tissue legislation to research in patients; - -Awareness of the applicability of good practice and guidance to research in patients

Desirable: - -Knowledge of data protection legislation; - -Knowledge of the UK Policy Framework for Health and Social Care Research; - -Good Clinical Practice

Essential: - Ability to demonstrate the organisational values and behaviours of the Trust