- To provide general and clinical trial contractual advice and expertise to colleagues in both the Enterprise Unit and the joint Clinical Research & Development Office at the Royal Marsden NHS Foundation Trust (RM).
- To draft, review, negotiate and conclude agreements that relate to clinical trials run by or at The ICR and/or RM.
- To identify and meet the expectations of stakeholders in performing the clinical trials contract function.
- To represent the ICR and/or RM in negotiations with prospective partners and sponsors and at trade shows and conferences
- To be a member of the Enterprise Unit team and contribute actively to team meetings
Under the direction of the Head of Clinical Trials Contracts and working closely with scientific colleagues at all levels in ICR and RM and with external legal advisors and insurers where necessary:
- Draft, review, negotiate and conclude (through to approval for signature) clinical trials-related contracts on behalf of the RM and The ICR and the Mount Vernon Cancer Centre (MVCC) including contracts with commercial and non-commercial sponsors and associated supplier and laboratory research contracts.
- Analyse the levels of risks posed in contracts and manage appropriately ensuring contracts are fair, equitable and enforceable.
- Manage and track all contracts using the contract record system including handling incoming requests from both external and internal parties and contract amendments.
- Work closely with study teams in RM and ICR to ensure that arrangements within clinical trials contracts meet all protocol and regulatory requirements and that key contractual obligations are identified.
- Where required, work with RM and ICR staff to ensure appropriate costing of research activities and pharmacy provision and governance of the clinical trial process in final contracts.
- Contribute as needed to the development of RM clinical research and development management systems.
- Advise senior management on rights, obligations and constraints in agreements and authorise them for signature.
- Build upon the existing relationships with the clinical study teams to develop an understanding of the nature of contracts management needed, including intellectual property protection.
- Maintain an up-to-date working knowledge of relevant legislation, codes of practice and guidelines governing clinical research managed and run at RM and The ICR through external training where appropriateand assess the impact of any changes.
- Provide advice and guidance to colleagues in the Enterprise Team, elsewhere in the ICR, the joint Clinical Research & Development Directorate and study teams with regard to contractual issues in the context of clinical research. Where appropriate contribute to training and development.
- Review and develop new template agreements as required to ensure compliance with regulatory and governance requirements.
- Work closely with colleagues in The Enterprise Unit to ensure that provisions in RMH clinical trial agreements do not conflict with undertakings in ICR collaborative research agreements.
- Negotiate and agree routine agreements such as material transfer agreement and confidentiality agreements relating to clinical trials.
- Reply promptly to queries from scientists, clinicians and study teams and keep them apprised of progress.
- Attend trial related meetings where needed.
- Depending on the skills of the post holder, develop areas of expertise in intellectual property management and commercialisation.
- Communicate verbally and in writing with internal (clinicians and researchers) and external parties (pharmaceutical companies, governmental entities, etc.) in a cordial, articulate and timely manner to build and develop an understanding of their needs and maintain fruitful relationships.
- Identify potential conflicts of interest between the objectives of the various stakeholders, and all other risks and liabilities and mitigate against their impact.
- Contribute to the review of the policies and procedures relating to clinical trials and related activities including insurance, IP management, governance and potential conflicts of interest.
- Contribute to regulatory and funder inspections as required.
- Attend and actively participate in Clinical R&D and Enterprise Unit meetings and contribute to discussions on strategic and general issues.
- Maintain sector awareness relevant to clinical trials at the ICR and RM
- Maintain and continue to expand established external networks, develop strategic relationships and promote partnering with the ICR and RM.
- Represent the ICR independently at trade exhibitions and conferences.
- Undertake occasional formal presentations within ICR or externally.
- Contribute to the development and maintenance of management information systems for contracts and other Enterprise Unit information; the preparation of management reports, metrics and other management information.
- Any other duties as may be required which are consistent with the nature and grade of the post.
This post will hold an honorary contract with the RM.
- Life Science degree.
- Extensive and recent practical experience of successfully drafting, negotiating and concluding contracts and closing deals with external partners.
- Comprehensive knowledge of contract law.
- Strong IT skills, with the ability to use computerised and web-based administrative systems and data sources effectively.
- Working knowledge of clinical trials, particularly related to applicable regulatory and ICH guidance regarding clinical research and GCP.
- Legal qualification.
- Experience of working with and applying the EU Clinical Trial Directive and other regulations appropriate to clinical trials run in the UK.
- Experience of working in the NHS or the higher education sector.
- Experience in the pharmaceutical or biotechnology sectors.