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Hello
I’m SHRIYA DAS
Clinical Trial Project Management And Trial Optimization Expert
A clinical trial optimization expert, proficient in orchestrating clinical trials to their highest potential. Skilled in devising and executing strategies to enhance trial efficiency, quality, and outcomes, while effectively leading cross-functional teams to surpass objectives.
WHAT I DO
FEATURES
WORK I DO
Clinical Operations
I oversee the planning, execution, and monitoring of clinical trials, ensuring compliance with regulatory standards.
Unit Supervision
I provide effective leadership and oversight to ensure smooth operations.
Regulatory Affairs
Ensure that medical products and treatments comply with regulatory standards and navigate the approval process for market authorization.
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
In Operations Oversight, I've ensured efficient and effective management of healthcare operations.
Project Implementation
Planning, organizing, executing, and monitoring all activities related to the clinical trial, ensuring that it adheres to timelines, budgets, and quality standards while coordinating the efforts of various stakeholders to achieve successful trial execution.
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%
WORK HISTORY
JOB EXPERIENCE
Project Manager, Clinical Operations at Compass Pathways - 11/2022 - Current
As a Clinical Project Manager, my role is pivotal in ensuring the successful planning, execution, and completion of clinical trials. I am responsible for overseeing the entire lifecycle of clinical projects, from protocol development to closeout activities. This includes coordinating and managing cross-functional teams, ensuring compliance with regulatory requirements, and maintaining a focus on patient safety and data integrity. I play a crucial role in budget management, resource allocation, and timeline adherence to meet project milestones effectively. My responsibilities also involve risk assessment and mitigation, as well as effective communication with internal and external stakeholders. Overall, as a Clinical Project Manager at Compass, I am dedicated to driving excellence in clinical trial execution and contributing to the advancement of healthcare and medical research.
PREVIOUS EXPERIENCE
Clinical Project Manager at Advenchen Laboratories
Led the successful management of global Phase II and Phase III oncology trials, providing strategic leadership and guidance to CROs and clinical site management teams throughout the trial lifecycle, from inception to completion. Directed feasibility activities critical to trial planning and execution.
Served as the Regulatory Manager and Safety Manager for assigned clinical trials, ensuring adherence to regulatory requirements and prioritizing patient safety. Managed global investigational sites to guarantee protocol compliance and overall alignment with clinical objectives.
Pioneered the development of Clinical Department SOPs and study guidelines/plans, actively contributing to the creation of essential study documents such as Protocols, ICFs, and other study materials. Oversaw strict compliance with the Clinical Monitoring Plan, including conducting site visits, reviewing and finalizing visit reports, and promptly addressing Protocol deviations as necessary.
Dedicatedly trained CRAs and PMs in the implementation of study protocols and Clinical operations SOPs, fostering operational excellence. Stepped in to provide crucial support to CRAs as a co-monitor at sites whenever required, ensuring the seamless execution of clinical trials.
Clinical Operations and Clinical Monitoring at Medpace
Supported the study team by managing ClinTrak modules, assisting with feasibility, and overseeing study supply distribution. I ensured TMF integrity, generated study documents, and collaborated effectively with Medpace and Sponsor teams.
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As a Clinical Research Associate (CRA) with experience in various Phase 1 to 3 studies, including medical device trials, I managed pre-study, initiation, monitoring, and close-out visits according to SOPs and GCP. I oversaw site management, scheduled monitoring visits, and maintained study databases. My role included Phase II and III Study Site management, ensuring subject safety, and conducting adverse event reporting. I also handled investigative site file reconciliation and maintained accurate Investigator Site Files (ISF) aligned with the Trial Master File (TMF).
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Assistant Professor at GD Rungta Arts, Science and Commerce College.
As an Assistant Professor, I instructed undergraduate and postgraduate courses in Molecular Biology and Recombinant DNA technology. I assessed and guided student activities, delivering comprehensive reports on their academic progress. I provided personalized assistance to students facing challenges, regularly monitoring their progress.
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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
EDUCATION
Degree Courses
Louisiana Tech University, Ruston, LA
Master of Science, Molecular Sciences and Nanotechnology
MGM School of Biomedical Sciences, Mumbai, India
Master of Science, Medical Genetics
MS Ramaiah College of Arts, Sciences, and Commerce, Bangalore, India
Bachelor of Science, Applied Genetics, Biochemistry and Microbiology
Certifications
DNA Fingerprinting certificate,
Chhattisgarh State Forensic Laboratory
Flow Cytometry certificate, JLN Medical College
Marketing certificate, The Wharton School, University of Pennsylvania
Healthcare Management certificate, eCornell
Initiating and Planning Projects certificate, UCI Extension
Budgeting and Scheduling Projects certificate,UCI Extension
Managing Project Risks and Changes certificate, UCI Extension
Analyzing Global Trends for Business and Society certificate, The Wharton School, University of Pennsylvania
Inspiring Leadership Through Emotional Intelligence certificate, Case Western Reserve University
Association of Clinical Research Professionals
Certified Professional (ACRP-CP®) certification
Publications
Research Papers
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Christen Boyer, J. Ambrose, S. Das, A. Humayun, W.C. Chastant, D. Chappidi and D.K. Mills, Antibacterial and Protein Repelling Clay Nanotube-Silicone Composites, (Journal of Materials Chemistry C, Royal Society of Chemistry- Accepted- 2015
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Das S.A study to understand the relation between fetal hemoglobin, the hematological parameters and Xmn 1 gene polymorphism. Ind J Med Healthc 1(9):2278–2266.2012
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Das S. Rapid One step DNA Extraction Method from (Gastrimargus Musicus) through Formaldehyde- Journal of Pharmaceutical and Biomedical Sciences
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Das S. To Analyze the Water Sample of Pond Located Near Nandani Mines in Durg District Chhattisgarh, India- Journal of Pharmaceutical and Biomedical SciencesBook
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Das S. The Relation between HbF, Hematological Parameters & XmnI Gene Polymorphism in LAP LAMBERT Academic Publishing. 2011
Book
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Das S. The Relation between HbF, Hematological Parameters & XmnI Gene Polymorphism in LAP LAMBERT Academic Publishing. 2011
Accomplishments
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Received the title of "Admirable Achiever" from the Kings Book of World Records for exceptional contributions in the field of Clinical Research.
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Was awarded the title of "Honor" for unwavering dedication to the clinical research industry by Exclusive World Records
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Award
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GOLD GLOBEE® WINNER 2023 for the Most Innovative Woman of the Year | Healthcare, Medical and BioTech
Publication
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