Open to opportunities

Sharanya Ramasubramanian

@sharanyaramasubraman

Message

I lead global oncology clinical trials, regulatory strategy, and high-performing operations teams.

United States

Message

What I'm looking for

I'm looking to lead global clinical operations and regulatory strategy for complex oncology, rare disease, or multi-therapeutic programs, where I can build teams, strengthen trial execution, and advance sponsor objectives with health authorities.

At CCS Associates, I lead program-level operations for Phase 1-3 oncology and multi-therapeutic trials, supporting IND, IDE, and NDA submissions—including an FDA-designated orphan drug program. I serve as a direct FDA liaison and oversee CRO partners and more than 50 global trial sites from set-up through close-out.

I manage two cross-functional teams across clinical operations, data management, and regulatory affairs, building SOPs, governance processes, and SharePoint and MS Project tracking tools. My teams have delivered 100% of sponsor milestones and improved TMF quality metrics by 40%.

Previously at Stanford University, I managed oncology and technology-driven studies involving wearables, applications, and devices. I developed protocols, ICFs, IRB submissions, and eTMF architecture; achieved full site enrollment within three months; and delivered first-patient-in nearly one year ahead of schedule.

Experience

Work history, roles, and key accomplishments

Current

Clinical Operations and Regulatory Operations, Senior Manager

Current

CCS Associates Inc.

Jan 2023 - Present (3 years 8 months)

Led program-level operational strategy for Phase 1-3 IND, IDE, and NDA submissions including an FDA-designated orphan drug program; served as direct FDA liaison for sponsor-agency communications. Managed two cross-functional teams of 7 direct reports using line and matrix management; developed SOPs, SharePoint and MS Project tracking tools, and weekly governance cadence across concurrent oncology