Senior CTM, Internal Medicine (Dermatology, Nephrology, Cardiovascular, Women's Health, GI, Immunology, Rare Disease)
Core
Manage clinical operational and quality aspects of moderate to high complexity studies to ensure final clean data deliverables meet customer time/quality/cost expectations.
Role type
Senior Clinical Trial Manager (Internal Medicine)
Builds
Clinical deliverables (clean data) for therapeutic areas including Cardiovascular, Nephrology, Dermatology, GI, Immunology, Rare Disease, Women's Health, and Endocrinology.
Domain
Clinical Research / Life Sciences
Required skills
Clinical monitoring, ICH GCP compliance, resource management, financial acumen, risk management, regulatory submissions, team leadership, project coordination
Preferred skills
Experience in Government & Public Health Studies (GPHS), regional lead responsibilities
Technologies
Outlook, Excel, Word, automated clinical systems
Responsibilities
Develop clinical tools (Monitoring Plans, Guidelines), manage clinical team and resources, ensure regulatory compliance and document quality, monitor study timelines and metrics, conduct field visits, coordinate start-up activities, prepare forecast estimates
Seniority
Senior, hands-on IC with potential for lead/manager responsibilities