Develop and manage study timelines, budgets, and resource plans Coordinate with internal stakeholders to align study objectives with business goals Proactively identify risks and implement mitigation strategies Author core clinical study documents, including protocols, ICFs, and CRFs Lead full study lifecycle execution from startup through closeout Prepare and manage IRB submissions, amendments, and continuing reviews Ensure studies are conducted in compliance with GCP and regulatory guidelines Design and oversee clinical data systems, including EDC and eTMF