At Cancer Research UK, we exist to beat cancer
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Cancer Research UK are looking for a Clinical Study Manager to join our Center for Drug Development (CDD), leading the multidisciplinary clinical study teams to ensure all clinical trial deliverables are met. This is a 2-year contract to support our platform trial, DETERMINE, which is the first UK national precision medicine trial in rare cancer.
The CDD is the world's only charity-funded drug development facility. Our pioneering research is driven purely by the goal to see scientific breakthroughs bring benefits to patients sooner. CDD is the sponsor of early phase and precision medicine clinical trials in oncology agents. Our broad portfolio rivals that of a medium-sized pharmaceutical company, spanning antibodies, cell therapies, vaccines, drug conjugates and small molecules, making this an interesting and dynamic area to work in.
You might be a Clinical Study Manager /Trial Manager or Clinical Trial Project Manager, with experience working on Oncology trials (ideally early phase but not essential). You might have experience within the NHS, Pharma, Biotech or come from an academic background. Whatever the sector, if you can demonstrate relevant skills in managing clinical trials we would love to hear from you.
This is an opportunity to work as part of a multidisciplinary project team in a well-structured process driven environment. You’ll have the opportunity to be involved in various stages of clinical trials from set up, recruitment through to closedown. We are passionate about our people and are dedicated to ensuring learning and development is built into your schedule, you’ll also be surrounded by people as dedicated to beating cancer as you.
What will I be doing?
1. Ensure all trial deliverables are met according to timelines, budget, operational best practices and compliance with Cancer Research UK SOPs, policies, the EU Directiveand ICH GCP guidelines
2. To define and agree the study timelines and milestones in conjunction with the study team for their inclusion into the overall project plan
3. To write and drive the preparation and review of the clinical study protocol and other study essential documents, according to the relevant SOPs
4. To identify and assess potential trial sites with relevant members of the study team and decide on suitable sites for the study. To negotiate agreements with NHS trusts, including the negotiation of clinical trial costs
5. To chair and facilitate study meetings with the internal teams, investigators and other key stakeholders and actively manage team actions, track study progress, and regularly communicate study progress to study team, Project Leader, Senior Research Manager and others as appropriate.
6. To interact with Investigator sites and the study team to ensure excellence of study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised
7. To liaise with the Medical Writing team for the delivery of the clinical study reports
8. To identify best practices, lead or contribute to continual improvement initiatives and implement new procedures for managing clinical studies
What are you looking for?
9. Biological Sciences degree or equivalent nursing qualification/experience
10. Experience of managing clinical studies (preferably including early phase oncology) – evidence of successful adherence to study timelines and an understanding of key issues surrounding trial management
11. Strong interpersonal skills with the ability to inspire effective teamwork and motivate members within a matrix system. Resolves conflict as needed.
12. Outstanding knowledge of ICH GCP, the UK clinical trial environment, drug development process and early phase clinical trials relevant to the pharmaceutical/biotech industry
13. Significant experience in project planning – and the tools used to do it
14. Excellent writing skills to enable drafting and creation of SOPs, protocols, NHS trust agreements and other relevant documents.
15. Strong negotiation skills to enable negotiation of costs and contracts
Our organisation values are designed to guide all that we do.
Bold: Act with ambition, courage and determination
Credible: Act with rigour and professionalism
Human: Act to have a positive impact on people
Together: Act inclusively and collaboratively
We’re looking for people who can believe in and embody these organisation values and can use them to drive forward progress against our mission to beat cancer.
If you’re interested in applying and excited about working with us but are unsure if you have the right skills and experiencewe’d still love to hear from you.
What will I gain?
We create a working environment that supports your wellbeing and provide a generous benefits package, a wide range of career and personal development opportunities and high-quality tools. Our policies and processes enable you to improve your work-life balance and take positive steps in your career.
You can explore our benefits by visiting ourcareers web page.
How do I apply?
We operate an anonymised shortlisting process in our commitment to equality, diversity and inclusion. CVs are required for all applications; but we won’t be able to view them until we invite you for an interview. Instead, we ask you to complete the work history section of the online application form for us to be able to assess you fairly and objectively.