Senior Manager, Participant Support
AtaiBeckley
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
Tech Stack
About the role
- Establish and oversee the sponsor's participant support framework across clinical development programmes
- Define the safety-focused support model, develop scalable training curricula for dosing session monitors
- Establish fidelity monitoring systems to ensure consistent, high-quality participant care and ensure regulatory compliance
- Serve as the internal subject-matter expert on participant support, providing scientific and operational leadership
- Collaborate with Medical, Clinical Operations, Regulatory Affairs, Quality Assurance, and Commercial functions
- Define and implement the participant support model, including terminology, competency frameworks, and operational workflows
- Develop participant-facing materials and facilitator resources including pre-dose education content and post-dose safety information
- Author and maintain participant support manuals and ensure version control
- Design, build, and deliver a scalable facilitator training curriculum covering patient assessment, monitoring, crisis management, and research ethics
- Implement qualification criteria and review processes to document monitor readiness and maintain training records
- Establish adherence and fidelity metrics for evaluating facilitator performance against the participant support manual
- Oversee systematic review of dosing session recordings and provide timely feedback to sites and dosing monitors
- Engage with investigators, site staff, and external researchers to incorporate emerging evidence and ensure the participant support model reflects current understanding
Requirements
- Master's degree or higher in psychology, nursing, social work, counselling, or a related mental health discipline
- Clinical licensure or registration preferred
- Minimum 3 years' experience in clinical research in psychiatry, neurology, or CNS drug development
- Demonstrated experience developing training curricula and competency assessment frameworks for clinical staff
- Experience with fidelity monitoring, treatment adherence assessment, or quality oversight in clinical trials
- Familiarity with participant support required in psychedelic research or altered-states monitoring preferred
- Experience working with CROs, training vendors, or external service providers
- Understanding of multi-regional trial requirements and cultural adaptation considerations
- Thorough understanding of ICH-GCP, FDA regulations, and clinical trial conduct requirements
- Knowledge of FDA draft guidance on psychedelic drug development
- Familiarity with EMA and MHRA regulatory frameworks for psychiatric drug development
- Strong written communication skills with demonstrated ability to author training manuals, SOPs, and regulatory documents
- Proficiency in developing and delivering training programmes across multiple modalities (in-person, virtual, e-learning)
- Experience with learning management systems, competency tracking tools, and training documentation
- Familiarity with electronic data capture systems and clinical trial documentation requirements
- Understanding of fidelity rating methodologies
- Excellent verbal communication skills for cross-functional collaboration, investigator engagement, and regulatory interactions
- Ability to influence without authority across matrix organisations
- Patient-centred mindset: Genuine commitment to participant safety, dignity, and wellbeing as the foundation of all decisions
- Scientific rigour: Evidence-driven approach to model design, training development, and quality assessment
- Pragmatic scalability focus: Ability to balance ideal-state frameworks with practical implementation constraints and commercial viability
- Resilience and composure: Calm, measured response to quality issues, safety signals, and challenging stakeholder dynamics
- Cultural humility: Sensitivity to diverse patient populations and international research contexts
- Collaborative leadership: Ability to build networks, mentor colleagues, and drive alignment across distributed teams without direct authority
- Ethical integrity: Unwavering commitment to GCP compliance, data integrity, and honest communication
- Intellectual curiosity: Engagement with emerging research, evolving regulatory guidance, and continuous improvement of practice.
Benefits
- Health insurance
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchtraining curriculum developmentfidelity monitoringtreatment adherence assessmentquality oversightparticipant supportpatient assessmentcrisis managementresearch ethicscompetency assessment frameworks
Soft skills
strong written communicationexcellent verbal communicationinfluence without authoritypatient-centred mindsetscientific rigourpragmatic scalability focusresilience and composurecultural humilitycollaborative leadershipethical integrity
Certifications
clinical licensureMaster's degree in psychologyMaster's degree in nursingMaster's degree in social workMaster's degree in counselling