Hello
I’m Shriya Das
Clinical Trial Project Management and Trial Optimization Expert
I specialize in advancing novel therapies through the strategic design and execution of high-impact clinical trials. Rooted in scientific integrity and driven by operational excellence, my work focuses on optimizing development pathways, minimizing risk, and elevating patient-centered outcomes. By leading cross-functional teams and applying precise, innovative strategies, I transform complex clinical trial ecosystems into streamlined, outcome-focused programs-ensuring that life-changing treatments are delivered with greater efficiency, safety, and certainty.
FIND ME

FEATURES
WORK I DO

Business
I lead global clinical trials with a focus on operational efficiency, regulatory compliance, and strategic execution—delivering innovative therapies through streamlined, scalable, and investor-aligned programs.

Unit Supervision
I lead cross-functional clinical operations units, ensuring protocol compliance, operational excellence, and alignment with global regulatory and financial objectives across complex, multi-site trials.

Regulatory Affairs
Ensure that medical products and investigational therapies comply with regulatory standards and successfully navigate the approval pathways for market authorization across global agencies, including the FDA (U.S.), MHRA (UK), EMA (EU), and MFDS (South Korea).

Risk Management
Plan, coordinate, and oversee all aspects of risk assessment and mitigation strategies within a clinical trial, ensuring that potential risks are identified, evaluated, and effectively managed to safeguard participants and the success of the study.

Operations Oversight
I provide effective leadership and oversight to ensure smooth operations across multiple global Phase I/II/III clinical trials, driving regulatory compliance, cross-functional alignment, and high-performance execution in complex therapeutic areas.

Clinical Delivery
Driving operational excellence in multiple global Phase I/II/III trials across diverse therapeutic areas, with deep expertise in start-up acceleration, recruitment optimization, and monitoring oversight across the U.S., U.K., Europe, APAC, Japan, South Korea, and South America.
FEATURES
PROFESSIONAL SKILLS
Expertise
CLINICAL TRIAL MANAGEMENT
100%
CLINICAL MONITORING
100%
FEASIBILITY AND SITE START-UP
100%
DATA MANAGEMENT
80%
QUALITY ASSURANCE
90%
VENDOR MANAGEMENT
100%
REGULATORY AFFAIRS
80%
Professional skills
LEADERSHIP
85%
STRATEGY
100%
PROBLEM SOLVING
100%
MENTORING
100%
TEACHING
100%
DATA REVIEW AND ANALYTICS
95%
BUILDING RELATIONSHIPS WITH PROFESSIONAL STAKEHOLDERS
85%
JOB EXPERIENCE
1
Project Manager, Clinical Operations at Compass Pathways
As a Clinical Project Manager at Compass Pathways, I lead Phase I–III clinical trials in the U.S. and U.K., advancing psychedelic research through strategic oversight and operational excellence. I manage all trial activities from study start-up to closeout, ensuring inspection readiness, regulatory compliance, and delivery on timelines and budgets.
My responsibilities include leading cross-functional teams, managing CROs and vendors, driving site activation, overseeing recruitment and monitoring, and resolving operational challenges in real time. I ensure GCP adherence and maintain quality across all phases, contributing to the successful execution of complex, high-impact studies that advance innovative mental health therapies.
2
Clinical Project Manager at Advenchen Laboratories
Led global Phase II and III oncology trials across the U.S., U.K., Spain, Italy, China, South Korea, and Japan—providing strategic oversight to CROs and clinical site teams from study start-up through closeout. Directed feasibility activities and ensured alignment with clinical objectives, regulatory requirements, and patient safety standards in my dual role as Regulatory and Safety Manager.
Managed investigational sites to ensure protocol compliance and operational continuity across regions. Spearheaded the development of Clinical Department SOPs, study plans, and critical documents including protocols and informed consent forms. Maintained strict adherence to the Clinical Monitoring Plan, conducted site visits, finalized monitoring reports, and addressed protocol deviations promptly.
Trained CRAs and PMs on protocol execution and operational SOPs, and served as a co-monitor when needed—ensuring high-quality trial conduct and inspection-ready documentation across all participating countries.
3
Clinical Operations and Clinical Monitoring at Medpace
Supported cross-functional study teams by assisting with feasibility assessments and coordinating study supply distribution to ensure site readiness. Maintained Trial Master File (TMF) integrity, generated essential study documentation, and collaborated closely with Medpace and Sponsor teams to support operational success.
As a Clinical Research Associate (CRA), I conducted Phase I–III clinical trials, including medical device studies, overseeing pre-study, initiation, monitoring, and close-out visits in compliance with SOPs and ICH-GCP. I managed site operations, scheduled and executed monitoring visits, and ensured data accuracy through study database oversight. My responsibilities also included subject safety monitoring, adverse event reporting, and reconciliation of Investigator Site Files (ISF) to ensure full alignment with the TMF, supporting audit readiness and regulatory compliance.
4
Assistant Professor at GD Rungta Arts, Science and Commerce College.
Taught undergraduate and postgraduate courses in Molecular Biology, Biochemistry, and Recombinant DNA Technology. Assessed student performance, provided academic guidance, and submitted detailed reports on academic progress. Delivered personalized support to students facing academic challenges, with regular follow-ups to promote improved comprehension and academic success.
I employed innovative teaching techniques to enhance student learning outcomes, administered exams, and facilitated remediation to help students achieve their educational goals. Additionally, I played a pivotal role in supporting weekly lab sessions in Genetic Engineering, Biochemistry, Molecular Biology, and Recombinant DNA technology, fostering student engagement, comprehension, and the attainment of learning objectives.
EDUCATION
Louisiana Tech University, Ruston, LA
Master of Science, Molecular Sciences and Nanotechnology
MS Ramaiah College of Arts, Sciences, and Commerce, Bangalore, India
Bachelor of Science, Applied Genetics, Biochemistry and Microbiology
MGM School of Biomedical Sciences, Mumbai, India
Master of Science, Medical Genetics
Research Papers
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Antibacterial and Protein Repelling Clay Nanotube-Silicone Composites
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A study to understand the relation between fetal hemoglobin, the hematological parameters and Xmn 1 gene polymorphism.
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Rapid One step DNA Extraction Method from (Gastrimargus Musicus) through Formaldehyde
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To Analyze the Water Sample of Pond Located Near Nandani Mines in Durg District Chhattisgarh, India
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Depression in Working Professionals – A Systematic Review of the
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Optimizing Clinical Trials Through Vendor Management
Research Papers
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Emotional intelligence and resilience: Key determinants of success in high-stakes scenarios
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Factors Influencing Timely Initiation of Clinical Trials: An Analysis of Start-up Phase Delays
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Diversity, Equity, and Inclusion (DEI) in Clinical Trials
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Embracing the Future: Opportunities and Challenges of AI Integration in Healthcare
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Investigating the safety and tolerability of single-dose psilocybin for post-traumatic stress disorder: A nonrandomized open-label clinical trial