Provide management oversight and reviews of study-related and essential study start-up documents to ensure quality, compliance and timely execution (e.g., Clinical Protocols, Informed Consent forms, Monitoring Plan, Clinical Product Management Plan, Clinical Safety Management Plan, Case Report Form [CRFs], CRF Completion Guidelines and other relevant documents). Proven ability to build strong relationships and communicate effectively across all organizational levels and with customers, fostering cross‑functional collaboration, proactively escalating issues, and leading joint initiatives to ensure timely resolution and project success aligned with strategic objectives.