Senior Manager, Participant Support

Role Overview:

The Senior Manager, Participant Support is responsible for establishing and overseeing the sponsor's participant support framework across clinical development programmes. This role defines the safety-focused support model, develops scalable training curricula for dosing session monitors, establishes fidelity monitoring systems to ensure consistent, high-quality participant care, and ensures regulatory and ICH-GCP compliance across global jurisdictions. The position serves as the internal subject-matter expert on participant support, providing scientific and operational leadership, partnering with Medical, Clinical Operations, Regulatory Affairs, Quality Assurance, and Commercial functions.

Key Accountabilities:

Participant Support Model & Standards (20%)

·        Define and implement the participant support model, including terminology, competency frameworks, and operational workflows aligned with the sponsor's approach and supports commercial scalability.

·        Develop participant-facing materials and facilitator resources including pre-dose education content, session guidance documents, and post-dose safety information. Ensure materials are aligned with study protocols, culturally appropriate for multi-regional use, and compliant with ICH-GCP and regional regulatory requirements.

·        Author and maintain participant support manuals in synchronisation with protocol development. Ensure version control and timely updates in response to protocol amendments or regulatory feedback.

Training Development & Delivery (30%)

·        Design, build, and deliver a scalable facilitator training curriculum covering patient assessment, monitoring, crisis management, non-directive communication, ICH- GCP and research ethics. Ensure training is deliverable through modalities that support timely global site activation.

·        Implement qualification criteria and review processes to document monitor readiness. Evaluate candidate credentials, clinical experience, and training completion prior to granting approval for study participation. Maintain training records to inspection-ready standards with full traceability of qualifications and ongoing professional development.

Fidelity Monitoring & Quality Oversight (35%)

·        Establish adherence and fidelity metrics, including rating, checklists, and assessment instruments for evaluating facilitator performance against the participant support manual.

·        Oversee systematic review of dosing session recordings to assess adherence to the protocol and training manual, identify training gaps, and generate actionable feedback. Establish sampling strategies, reviewer training protocols, and documentation standards to support regulatory inspection readiness.

·        Generate timely feedback to sites and dosing monitors, including specific remediation recommendations. Escalate quality or safety signals through appropriate channels and document resolution to inspection-ready standards.

Cross-Functional Collaboration & Stakeholder Management (approximately 15%)

·        Serve as the internal participant support subject-matter expert, reviewing study protocols, case report forms, informed consent documents, investigator brochures, and clinical study reports to ensure participant support elements are appropriately captured and scientifically justified.

·        Provide scientific and operational oversight of external participant support vendors, including training providers and technology platforms. Define deliverables, monitor performance against contractual obligations, and ensure vendor activities align with sponsor standards and regulatory requirements.

·        Partner cross-functionally with Medical Affairs, Clinical Operations, Regulatory Affairs, Quality Assurance, and Commercial to ensure participant support considerations are integrated into study design, site selection, regulatory submissions, audit preparedness, and commercial readiness planning. Contribute to regulatory interactions and inspection preparation as the participant support expert.

·         Engage with investigators, site staff, and external researchers to incorporate emerging evidence, optimise training methodologies, and ensure the participant support model reflects current understanding and best practices across FDA, EMA, and MHRA jurisdictions.

Required Qualifications

Education

·        Master's degree or higher in psychology, nursing, social work, counselling, or a related mental health discipline

·        Clinical licensure or registration (e.g., registered psychologist, independent mental health nurse practitioner, licensed clinical social worker) preferred

Experience

·        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

 Regulatory Knowledge

·        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

Required Skills

Technical Skills

·        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

·        Ability to interpret session recordings and provide constructive performance feedback

Collaboration & Communication

·        Excellent verbal communication skills for cross-functional collaboration, investigator engagement, and regulatory interactions

·        Ability to influence without authority across matrix organisations

·        Skilled at translating complex clinical and regulatory requirements into practical operational guidance

Personal Attributes

·        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