Senior Trial Manager

at  Kings College London

Job id: 100006. Salary: £44,105 - £51,485 per annum, including London Weighting Allowance.
Posted: 15 November 2024. Closing date: 20 November 2024.
Business unit: IoPPN. Department: Forensic & Neurodevelopmental Sciences.
Contact details: Professor Andre Strydom. andre.strydom@kcl.ac.uk
Location: Denmark Hill Campus. Category: Professional & Support Services.
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About us
The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) is a leading centre for mental health and neuroscience research in Europe. Research from the IoPPN has made, and continues to make, an impact on how we understand, prevent and treat mental illness, neurological conditions and other conditions that affect the brain.
The Department of Forensic and Neurodevelopmental Sciences (FANS) is one of Europe’s largest research groups and bringing together leading experts in brain development and neurodevelopmental conditions. We focus on understanding developmental brain conditions to identify and then trial suitable treatments to improve outcomes into adult life.
About the role
The post holder will be responsible for managing several industry-sponsored trials and observational studies. Our clinical trials centre specialises in trials of treatment for individuals with neurodevelopmental conditions such as autism, intellectual disability, Down syndrome and other genetic conditions associated with intellectual disability. At present, we typically host two -three such trials at a time. In addition, we undertake several observational studies focussed on Alzheimer’s disease in people with Down syndrome, funded by major UK and international funders.
The successful candidate will have overall management responsibility of the clinical study operations, which includes taking care of regulatory aspects and ethics applications, site management, resources management, staff training and monitoring progress to ensure key project deliverables. They will be liaising with UK/European/International and industry partners and will enable systems and processes for the smooth running of the clinical trials within each project. They will draw on support from other experts and the clinical trials infrastructure at IoPPN and King’s health partners, including a clinical trials office, a clinical research facility, and a clinical trials unit.
The co-ordinator will be further supported by input from an administrator for day-to-day tasks. The clinical trials centre has access to medical and nursing support, and observational studies have a number of staff undertaking assessments (Research assistants, PhD students and post-doctoral fellows).
With input from the principal investigator, they will help to coordinate the studies, develop additional funding applications, and consolidate the project outputs. They may be required to line manage research workers and/or student projects.
This is a full-time post (35hours per week) which will be offered on a fixed-term contract until 31 December 2025.
About you
To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria

• Degree in a science subject (or equivalent) and a post graduate qualification with a research methodology element
• Experience of working on clinical trials (CTIMPs), gained in multi-centre, phase II and/or phase III, randomised trials, with an understanding of GCP guidelines
• Experience of preparing regulatory and ethics submissions and amending protocols, participant information sheets, electronic databases and other relevant trial management documentation
• Knowledge of project management methodology and commitment to acquire complete project management skills
• Excellent organisational skills with an ability to predict, identify and resolve problems that are critical to the running of the trial and plan strategically to avoid them
• Excellent IT skills including working with complex databases and electronic clinical trial management systems
• Excellent verbal and written communication skills, particularly in the context of scientific writing, reports, presentations, and telephone manner.
• Willing to travel with the UK flexibly to accommodate the needs of the project

Desirable criteria

• PhD or Formal qualification in clinical trials (or working towards one)
• Experience of financial planning and implementation
• Experience of supervising other staff
• Experience in the field of study of the trial
• Previous experience of writing written procedures

Downloading a copy of our Job Description
Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the next page after you click “

Please refer the Job description for details