The Clinical Project Manager will be responsible for leading a number of important global studies that are both underway and planned. The Project Manager will be passionate about developing innovative treatments to improve the lives of patients with mental health disorders. They will be responsible for supporting the planning, coordination, and implementation of clinical research projects within budget, timeline, and scope. They will also monitor and present project updates to relevant stakeholders, clients, or project team members.
COMPASS Pathways plc is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support.
COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com
Location: Home based in United States (East Coast) or Office based in New York.
Reports to: The Clinical Project Manager will report to the Vice-President, Clinical Operations.
Roles and responsibilities
Responsibilities include (but are not limited to):
- Oversight of CRO(s) working with COMPASS
- Collaboration with CRO(s) to ensure delivery of projects on-time, to the required quality and within budget
- Working directly with site teams and local/national health services located globally to stimulate patient recruitment and retention
- Working directly with sites located globally on Investigator Instigated Studies, including contractual agreements and provision of clinical supplies
- Other duties as appropriate to support the Clinical Operations team
- Clinical research experience including managing full-service projects
- Experience in Pharma/Biotech, CRO and/or academic research is essential
- An inquiring mind and great enthusiasm to work in an exciting and fast-moving environment
- Knowledge of ICH and GCP guideline
- Ability to operate independently and in cross-functional teams
- Aligned to our company mission and values of Compassionate, Bold, Rigorous and Inclusive