Sr. Clinical Trial Manager

Role: Senior Clinical Trial Manager (SCTM) leading global Phase II clinical studies for a biopharma focused on small molecule treatments for cardiovascular, metabolic, and pulmonary diseases. Responsibilities: oversee day-to-day trial operations, manage CROs and internal stakeholders, coordinate study start-up, conduct, and close-out activities; develop and review study documents; ensure compliance with SOPs, ICH/GCP, and regulatory guidelines; monitor study progress, timelines, budgets, and data integrity; support inspection readiness and regulatory submissions. Qualifications: Bachelor's degree in scientific or healthcare discipline; 7+ years in clinical research with at least 3+ years of study management experience; experience managing multinational studies, sites, CROs, and vendors; strong knowledge of FDA/EU regulations, ICH, and GCP; proficient in MS Office. Preferred: experience with global teams, SOP development, and supporting regulatory documentation. High-Value: focus on Phase II, multicenter trials, working across US and Asia-Pacific regions, with up to 30% travel; emphasis on clinical operations within early to mid-stage drug development for chronic diseases using small molecules.