Open to opportunities

Sovan Das

@sovandas

I am a clinical operations leader delivering Phase III oncology and vaccine trials with measurable process improvements.

United States

Message

What I'm looking for

I’m seeking a clinical operations leadership role overseeing Phase II/III oncology or vaccine trials, where I can mentor teams, optimize site performance, manage vendors, and drive timely, compliant study delivery in a collaborative, quality-focused environment.

I am a clinical operations leader with 7+ years leading U.S. Phase III oncology and vaccine trials, directing site operations, CRA oversight, and vendor partnerships. I thrive under pressure and use structured decision-making to reduce deviations and accelerate timelines.

At Merck I managed two pivotal Phase III Gardasil studies across 34+ sites and 15 CRAs, reviewed 200+ monitoring visits, and cut protocol deviations by 30% within six months. I co-led start-up activities for dengue and RSV trials, shortening startup timelines and ensuring protocol compliance across 15+ sites. I also owned end-to-end data management, driving 30% faster query resolution and 100% on-time milestone delivery.

I prioritize cross-functional collaboration, mentor teams, and implement process improvements such as CTMS-driven escalations and global SharePoint resources to boost performance. I’m ready to lead clinical operations in a mission-driven organization focused on timely, compliant trial delivery.

Experience

Work history, roles, and key accomplishments

Clinical Research Manager

Merck & Co.

Dec 2022 - Mar 2025 (2 years 3 months)

Directed U.S. clinical site operations for two pivotal Phase III Gardasil vaccine studies across 34+ sites and 15 CRAs; reviewed 200+ monitoring reports, reduced protocol deviations by 30%, and improved site compliance by 25%.

Clinical Operations CTMS Vendor Management Risk Mitigation Monitoring GCP)Stakeholder Engagement GCP

Associate Clinical Trial Manager

Merck & Co.

Jan 2021 - Dec 2022 (1 year 11 months)

Supported Phase III RSV and dengue trials, leading Medidata eCOA/ePRO device start-up, UAT, device workflow configuration, and site training; coordinated cross-functional teams and vendors to achieve 100% on-time database milestone delivery.

ECOA UAT Device Workflow Database Lock Query Resolution Cross Functional Collaboration Clinical Data Management

Clinical Data Manager

Merck & Co.

Sep 2019 - Jan 2021 (1 year 4 months)

Owned end-to-end data management for global Phase II/III oncology trials, cutting query turnaround by 30% and reducing query volume by 20% through CRF design, validation plans, and SAE reconciliation to enable cleaner interim analyses.

Data Management CRF Design Data Validation Query Management SAE Reconciliation Root Cause Analysis ICH GCP

Global Data Management & Standards Co-op

Merck & Co.

Jan 2019 - Sep 2019 (8 months)

Contributed to SOP revision projects and developed TMF impact assessment tools for global studies to improve documentation controls and study readiness.

SOP Development TMF Documentation SharePoint Collaboration

DMPK Co-op

GlaxoSmithKline

Jan 2018 - Jun 2018 (5 months)

Conducted LC/MS method development for 150+ compounds and supported preclinical bioanalysis using Analyst software to deliver robust DMPK data for stress and repair studies.

LCMS Method Development LC MS Method Development Analyst DMPK Studies

Global Regulatory Affairs Intern

Merck & Co.

May 2017 - Aug 2017 (3 months)

Supported CAPA projects and audit readiness within the regulatory clinical safety group, designing training tools and tracking resolution of inspection findings to improve compliance.

CAPA Regulatory Training Development Inspection Findings Tracking GCP)GCP

Education

Degrees, certifications, and relevant coursework

Temple University

Bachelor of Science, Biology

Completed Bachelor of Science in Biology in May 2019 at Temple University, Philadelphia, focusing on core biological sciences and laboratory coursework.