Associate Manager, Clinical Care Operations

Compass Pathways, Inc.; Jersey City (NJ); Hybrid; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

Compass Pathways, Inc. is seeking an Associate Manager in Clinical Care Operations to help scale training across North America, Europe and Australia for our experimental COMP360 program.

The role trains and supports clinical site staff, coordinators, and CRO partners, ensuring documentation and compliance throughout trials. The position is hybrid with a Jersey City office or East Coast remote option, requiring cross-time-zone coordination, strong project management, and keen attention to

Qualifikationen

• 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 across time zones and managing consultants/vendors.
• Strong Excel skills and experience with project management software (Smartsheet, Trello, Jira).
• Experience managing events with Zoom; Rise e-learning tool and AV editing experience preferred.
• Experience with complex record keeping in a regulated setting; knowledge of GCP, ICH guidelines, FDA regulations preferred.

Aufgaben

• Schedule training events across time zones.
• Support live online trainings and ensure smooth operations.
• Coordinate with trainers and CRO to ensure on-time training completion and documentation.
• Oversee CRO training activities as assigned.
• Assess trainee competency and escalate concerns to leadership as needed.
• Update training materials and manage content using Rise and related tools.
• Support inspection readiness through compliant training documentation.
• Support additional tasks as needed by R&D Operations.

Kenntnisse

Scheduling across time zones

Vendor/consultant management

Excel

Smartsheet/Trello/Jira

Zoom training events

Rise e-learning tool

Video/Audio editing

GxP / GMP knowledge

GCP/ICH/FDA regulatory

Ausbildung

Bachelor’s degree in life or social sciences

Tools

Smartsheet

Trello

Jira

Jobbeschreibung

Associate Manager, Clinical Care Operations

United States

Company introduction:

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology companydedicatedto 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:

• 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
• Oversight of CRO training activities, as assigned
• 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.

These include f lexibility & generous time off, parental & reproductive support, health & medical, mental health & wellbeing and Financial health.

Equal opportunities:

Reasonable accommodation

We are committed to building a workplace where everyone’s wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know.

UK applicants

We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability.

US applicants

Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.

Sponsorship :

Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.

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