Oversees and supervises clinical operations team and CROs (as applicable) and ensures that these activities are conducted in accordance with applicable regulatory requirements and guidelines including Nevia standard operating procedures, ICH-GCP guidelines, regulatory authority regulations, and patient safety standards, as applicable.

Creates, executes and proactively manages clinical study processes.

Develops clinical study protocols, source documents/CRFs, study monitoring plans, and data management plans and execution.

Perform all study related activities including SQV, SIV and site monitoring visits.

Ensures the identification, recruitment, and selection of appropriate clinical investigators and CROs (as applicable) as well as the appropriate negotiations of contracts.

Ensures successful and timely recruitment of appropriate clinical study participants in line with company goals.

Establishes performance indicators to ensure the successful execution of clinical studies in line with company timelines.

Oversee, plan, and implement all activities required for the generation of high-quality data deliverables on time and on budget (e.g., development of case report forms, collaboration with statisticians, collaboration with data managers, data overview, clinical study reports, etc.).

Leads and mentors the clinical operations team.

Provide periodic status updates and effectively communicate with the Management Team, Project Teams, Board of Directors, and other key internal stakeholders.

Develop and maintain strong relationships with external experts, and Investigators to ensure the effective execution of internal and external clinical projects.

Provide support for regulatory submissions, supporting dossier development, and participating in interactions with applicable worldwide regulatory agencies.

Remains up-to-date with current information on clinical study regulations, guidelines, and practices to ensure consistent best practices across all activities.