Manager, Clinical Trial Disclosure

Redaction of clinical trial documents in accordance with evolving global regulations.

Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation"and other regulations.

Manage and Coordinate redaction of clinical documents in accordance with EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations.

Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements.

Manage and track redaction book-of-work; compile and report on volume and performance metrics.

Provide operational support to CT Results Managers, as required.

Assist in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements ".

Communicate with internal and external stakeholders to improve on processes and manage unmet need ".

Train new staff and develops job aids, work instructions, and user guides, as needed".

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