Research Contracts Manager

The Christie International; Manchester; On-site; GBP 60,000 - 85,000; Full time

Job summary

The Christie NHS Foundation Trust in Manchester is seeking a Contracts Manager to advise research colleagues on contracting arrangements for clinical trials and other research projects, including data protection, IP and funding terms.

The post holder will negotiate with pharmaceutical sponsors, NHS organisations, universities and sponsors, ensuring robust, compliant contracts and offering training to the research delivery teams to manage risk and protect patient interests.

Qualifications

• Knowledge of contracts and data protection in clinical research.
• Experience preparing, reviewing and negotiating contracts for research.
• Ability to build strong working relationships with research teams and external partners.

Responsibilities

• Advise on contracting arrangements for clinical trials and research projects.
• Negotiate and draft contracts with sponsors, NHS organisations, academic partners and industry.
• Provide training on contract issues to research delivery teams.

Skills

Contract negotiation

Legal drafting

Stakeholder liaison

Job description

The Christie NHS Foundation Trust is an international leader in cancer research. We aim to be one of the world’s leading centres for research involving patients with cancer. We work to transform the detection of illness and clinical care of patients by undertaking innovative research to improve the outcomes of their care.

Research at The Christie is managed through robust governance measures. At the heart of these is the negotiation of contracts which protect the interests of patients and manage risk. The delivery of contracts in good time is essential for securing sustainable funding from commercial, charitable and public sources.

This is an excellent opportunity for someone with strong contract negotiation and preparation skills who is enthusiastic about offering patients more opportunities to participate in clinical research.

Training will be provided, if required.

Flexible working arrangement requests will be considered, and we support requests for secondment from other roles in patient research in the NHS.

We welcome informal discussion about the role before applying.

Main duties of the job

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.

Working for our organisation

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.

Detailed job description and main responsibilities

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 Trust’s 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 Trust’s 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

The post holder will be expected to:

• 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 Trust’s approach to research when dealing with commercial organisations, regulatory bodies, academic institutions and other NHS organisations.

4. Knowledge, training and experience

The post holder will be required to:

• 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 post holder will organise activities or programmes to deliver plans for improvement by arranging meetings, ensuring outcomes are followed up, notifying appropriate colleagues of any matters concerning finance, research governance, risk and quality and gaining senior management approval to plans where appropriate.

• The post holder will mostly work independently but will be expected to seek guidance from R&D Solicitor Consultant and, where appropriate, other colleagues on sensitive or difficult issues arising in relation to trial or other research contracts.

• The post holder will prioritise his or her own workload but will also work flexibly to meet deadlines as required.

• Demonstrates the agreed set of Trust values and accountable for own attitude and behaviour.

Person specification

Qualifications

• - Knowledge of written contracts gained through experience or relevant post graduate qualification

Experience

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

Skills

• - 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

Knowledge

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

VALUES

• Ability to demonstrate the organisational values and behaviours of the Trust

The closing date for this post may be extended if there are insufficient applicants or brought forward if there is a high volume of applicants.

Application Information - If you have not heard from us within four weeks of the closing date, I regret that on this occasion your application will have been unsuccessful.

Sponsorship Information - We are an approved sponsoring organisation. Applications will be considered from applicants requiring sponsorship alongside all other applications. Please be aware, not all roles are eligible for sponsorship. You can review the list of eligible role and requirements on the government website.

Pre-Employment Checks - To confirm your suitability for the role, we will carry out pre-employment checks in line with NHS Employment Check Standards . These include:

• Identity verification
• Right to work check
• Disclosure and barring service (DBS)/Criminal record check (dependent on role, payment of this will be the applicants responsibility)
• Professional registration and/or qualification check
• Occupational health assessment
• Employment history and reference validation

All applicants external to The Christie NHS Foundation Trust will be required to provide their HMRC employment history to cover the most recent three years employment. This information will used to validate employment history andreferences.

If you require sponsorship, we will assess your eligibility based on current government guidance. If the role is not eligible and you cannot demonstrate your right to work, your conditional offer may be withdrawn.

If You're Offered the Role - you will be agreeing to The Christie NHS Foundation Trust transferring the information contained in this application to its preferred applicant management system. If you are offered a job information will also be transferred into the national NHS Electronic Staff Records system. Please note, all communication regarding your application will be made via email, please ensure you check your junk/spam folders as emails are sometimes filtered there.

The Inter-Authority Transfer (IAT) process is a critical and beneficial component of ESR and will form part of the recruitment process. In the event that you are successful following interview your previous NHS employment data, if applicable will be transferred from your current / most recent employer.

No Smoking Policy - You should be aware the Trust operates a No Smoking Policy and therefore employees are not permitted to smoke at work.

Additional Information - We want to ensure that everyone who works at the Christie or uses our services is welcomed, valued and treated with dignity and respect.The Christie values diversity and is committed to ensuring equal opportunities for all and fair representation across the organisation at all levels. In support of these commitments, we particularly welcome applications from Black, Asian and other ethnic minority people and people with disabilities for this post. Appointment will be only on merit.

We are committed to creating a balanced and diverse workforce. As such we welcome and encourage applications from people of all backgrounds. Together we will foster inclusion and tackle inequity and health inequalities in cancer care.

As users of the disability confident scheme, we guarantee to interview all disabled applicants who meet the minimum criteria for the vacancy.

The Christie NHS Foundation Trust is committed to the highest standards of ethical conduct and integrity in all our activities. We have a zero-tolerance approach to modern slavery in any of its forms, including slavery, servitude, forced or compulsory labour, and human trafficking. We are fully committed to acting ethically and with transparency in all our business dealings and relationships, and to implementing and enforcing effective systems and controls to ensure modern slavery is not taking place anywhere in our organisation or supply chains.

Employer certification / accreditation badges

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Name April Marland Job title Solicitor Consultant Research and Innovation Email address [e-mail] Additional information

By email. Calls may be arranged on receipt of email if suitable for recruiters and enquirers.