Clinical Trial Manager - Mental Health / Psychedelics
|Jul 03, 2021
|Focus / Industry:
Lead the design and execution of clinical research at a rapidly growing psychedelic-assisted therapy startup | Opportunity to help change the face on mental healthcare | Competitive salary and equity options available
Clerkenwell Health is an innovative UK-based mental health biotech focussed on the research and delivery of psychedelic-assisted therapies. These revolutionary treatments have the potential to change the face of mental healthcare. At Clerkenwell we are positioning ourselves at the forefront of this shift by supporting the 80+ psychedelic drug manufacturers with the design and implementation of their clinical trials.
Having closed an initial funding round in March we are now recruiting an ambitious and process-oriented clinical trials manager to join our team. As part of a young start-up this role will be broader than one in a traditional CRO organisation and we are looking for an entrepreneurial individual eager to learn fast and grow with the business.
The successful applicant will have experience of designing trial protocols and associated regulatory packages in the UK.
● Input to design of trial protocols
● Coordination of regulatory submissions
● Support with the project management of studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results across feasibility and site selection, recruitment, execution and close out
● Accountable for management of protocols in compliance with UK regulations, quality standards and adverse event reporting requirements internally and externally.
● Accountability for the delivery of studies according to agreed SOPs, budgets and timelines
● Vendor management (when appropriate - may include outsourcing activities to CTUs or other CROs)
● Review monitoring visit reports and QA findings
● At least 4 years experience with clinical trials
● Experience in Pharmaceutical/Biotechnology/Medical Device
● Proven success in leading complex clinical trials
● Vendor management
● Experience navigating UK regulatory bodies
● Strong project management and planning abilities
● Comfort working in a fast-paced environment and navigating certain amounts of ambiguity
● RWE or observational trial design
● Interest in psychedelic-assisted therapies and/or mental healthcare
● Experience working with mental health-based trials