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 & Tools
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