Associate Manager, Clinical Care Operations

Company introduction

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care.

The Company is headquartered in London, UK, with a U.S. office in New Jersey. We believe mental health patients deserve the possibility of a better future. Our initial focus is developing COMP360 psilocybin, a proprietary, investigational, synthetic psilocybin treatment under evaluation for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). COMP360 is a potentially first-in-class treatment and has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD.

We are leading the world's largest classic psychedelic clinical program in TRD, and building upon that robust foundation, we are executing a late-stage trial evaluating COMP360 for PTSD, another condition with high unmet need. Our goal is to advance treatments that move the field of psychiatry towards treatment options that offer rapid onset and sustained durability with infrequent dosing. - Compass Pathways

Job overview

The Clinical Care Operations department at Compass leads and oversees implementation of necessary trainings of personnel at clinical trial sites to deliver psychedelic treatment to trial participants. The Associate Manager, Clinical Care Operations will play an important role in the startup and ongoing support of our clinical trials by managing operations to train support providers working on our clinical trials.

Support providers are integral in preparing participants for their COMP360 treatment sessions, providing monitoring and support during the sessions, and then supporting the participant's self-directed integration (or processing) of their experiences. This position will work directly with our trainers and CRO partners, as well as with key internal stakeholders.

This position will be responsible for scheduling, running, supporting, and documenting training completion for support providers at clinical trial sites across North America, Europe and Australia. Flexibility to work across time zones, attention to detail, strong initiative, teamwork and sense of accountability will be important in this role.

Location: Hybrid in our Jersey City office or remote on the East Coast in the United States.

Reports to: Associate Director, Clinical Care Operations.

Roles and responsibilities

(Include but are not limited to)

• Schedule training events across time zones
• Support smooth operations for live online trainings
• Partner with trainers and CRO to ensure on-time training completion and training documentation
• Oversight of CRO training activities, as assigned
• Assess support provider competency during training, ensuring alignment with the training requirements, and escalating any concerns to clinical and operational leadership as needed
• Manage updates to support provider training materials, including project management, content drafting, managing consultant work, coordination of stakeholder review, and making updates on the Rise e-learning authoring tool used for training content
• Support inspection readiness through adherence to processes, as well as timely, accurate and complete documentation of training activities
• Additional tasks as determined by R&D Operations team
• Accountable for compliance with ethical and scientific standards, regulatory requirements, and the Compass Quality Management System, ensuring participant safety, data integrity, and accuracy throughout the trial process

Candidate Profile

• 3-5 years of experience in clinical research operations or training operations in a clinical research setting, Pharma/Biotech, CRO, EdTech or mental health startup
• Experience scheduling events/meetings across time-zones as well as consultant/vendor management and/or customer service required
• Strong excel skills and experience with project management software such as Smartsheet, Trello, or Jira required
• Experience managing events with Zoom (ie. scheduling settings, managing breakout rooms, sharing video/audio) preferred. Experience with the Rise e-learning authoring tool and audio/video editing software preferred
• Experience with complex record keeping in a highly regulated setting required; experience with Quality Management Systems and eTMF filing as well as knowledge of, and experience working with, GDocP strongly preferred
• Highly operational and detail-oriented, able to get things done quickly while ensuring attention to detail and clear communication
• Thrives in a fast paced and continually changing environment with drive to take initiative and commitment to collaboration
• Ability to work flexible hours occasionally to support training across time zones
• Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulation
• Bachelor's degree, preferrable in life or social sciences areas or equivalent experience

Compensation Description (annually)

Our compensation package for permanent hires includes base salary, discretionary bonus, and equity, alongside our comprehensive benefits offering.

Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

Base salary per annum: $90,000 - $120,000 USD

Benefits

• For an overview of our benefits package and compensation information, please visit " Joins us - Our Benefits ".
• These include f lexibility & generous time off, parental & reproductive support, health & medical, mental health & wellbeing and Financial health.