Clinical Study Manager

4,000 professionals, 0 days wasted, 1 incredible purpose. Together, we are beating cancer.
2 x Clinical Study Manager - Centre for Drug Development
Salary: £50,000 - £55,000 pa + benefits
Contract type/ hours: 1 x Permanent 1 x Fixed term contract for 24 months / full time 35 hours (flexible working requests for 4 day working week considered)
Location: Stratford, London (High flex - we'd expect you to be in the office 1 or 2 days a week) or Home -based within the UK.
Department: Research and Innovation
Reports to: Senior Research Manager
Application Deadline: Wednesday 7th February at 23.55. This vacancy may close earlier if a high number of applications are received or once a suitable candidate is found, so please do not delay submitting your application to avoid any disappointment.
Recruitment process: Shortlisted candidates will be asked to complete a competency interview.
At Cancer Research UK, we exist to beat cancer
We are professionals with purpose, beating cancer every day. But we need to go much further and much faster. That's why we we're looking for someone talented, someone innovative and ambitious, someone like you.
The Cancer Research UK Centre for Drug Development (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.
What will I be doing?
We're looking for two Clinical Study Managers to join the CDD team and lead the multidisciplinary Clinical Study teams to ensure all clinical trial deliverables are met.
Key duties include:
Ensure all trial deliverables are met according to timelines, budget, operational best practices and compliance with Cancer Research UK SOPs, policies, the EU Directive and ICH GCP guidelines
To define and agree the study timelines and milestones in conjunction with the study team for their inclusion into the overall project plan
To write and drive the preparation and review of the Clinical Study protocol and other study essential documents, according to the relevant SOPs
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
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.
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
To liaise with the Medical Writing team for the delivery of the Clinical Study reports
To identify best practices, lead or contribute to continual improvement initiatives and implement new procedures for managing clinical studies
What skills are we looking for?
Biological Sciences degree or equivalent nursing qualification/experience
Experience of coordinating clinical studies or monitoring them (preferably including early phase oncology) - evidence of successful adherence to study timelines and an understanding of key issues surrounding trial management
Strong interpersonal skills with the ability to inspire effective teamwork and motivate members within a matrix system. Resolves conflict as needed.
Outstanding knowledge of ICH GCP, the UK clinical trial environment, drug development process and early phase clinical trials relevant to the pharmaceutical/biotech industry
Significant experience in project planning - and the tools used to do it
Excellent writing skills to enable drafting and creation of SOPs, protocols, NHS trust agreements and other relevant documents.
Strong negotiation skills to enable negotiation of costs and contracts
What will I gain?
Each and every one of our employees contributes to our progress and is supporting our work to beat cancer. We think that's impressive.
In return, we make sure you are supported by a generous benefits package, a wide range of career and personal development opportunities and high-quality tools, policies and processes to enable you to do your job well.
Our benefits package includes a substantial retirement plan, a generous and flexible leave allowance, discounts on anything from travel to technology, gym membership, and much more.
We review pay annually and aim to recognise individual performance and achievements.
We don't forget people have lives outside of work too and so we actively encourage a flexible working culture.
Our work - from funding cutting-edge research to developing public policy - will change the world. It's exciting to be part of our team.
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 quickly, fairly and objectively.
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