Manager, Clinical Trial Disclosure

Manage and coordinate redaction of clinical trial documents in accordance with EMA Policy 0070, Health Canada PRCI, and EU Clinical Trial Regulation.

Collaborate with Global Development Operations, Medical Writing, Biostatistics, and Regulatory Submission Managers to operationalize document disclosure requirements.

Oversee third-party vendors supporting data anonymization, document redaction, and clinical trial data sharing workflows.

Develop training materials, job aids, work instructions, and change management strategies for evolving global clinical disclosure regulations.

Track the redaction book-of-work, measure operational performance metrics, and assist CT Results Managers with regulatory submissions.