Shriya Das
Flower Mound,TX
Summary
Clinical Trial Optimization Expert | Driving Operational Excellence
Distinguished expert in Clinical Trial Optimization, dedicated to advancing novel therapies through innovative strategies that enhance trial efficiency, regulatory compliance, and patient outcomes. Over a decade of experience in clinical research project management, leading transformative initiatives that refine trial design, streamline operations, and drive the seamless execution of complex studies. Expertise lies in orchestrating multidisciplinary teams, integrating cutting-edge methodologies, and ensuring the highest standards of clinical excellence. A recognized thought leader in the field, with published contributions on optimizing clinical operations, particularly in vendor management, demonstrating a deep understanding of process refinement critical to trial success. A meticulous, results-driven approach combines strategic vision with operational precision, ensuring that clinical programs not only meet regulatory and scientific rigor but also accelerate the delivery of life-changing therapies. A strong commitment to innovation and efficiency has positioned this expertise at the forefront of shaping the future of clinical research.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Clinical Project Manager
Compass Pathways
11.2022 - Current
- Manage various vendors working in the assigned clinical trials
- Manage global investigational sites to ensure compliance with protocol and overall clinical objectives
- Identify opportunities to improve clinical practices, devise strategies and implement plans to increase patient care standards and enhance operational procedures
- Communicate effectively with staff members, physicians, and patients, employing active listening and interpersonal skills
- Delegate tasks to staff members, monitor completion of all duties and provide support to enhance performance
- Review operational policies and recommend solutions and changes to medical director.
- Coordinated site visits and audits for ongoing quality assurance during all phases of the clinical trial process.
- Conducted thorough risk assessments for each project, proactively mitigating potential issues before they escalated.
- Enhanced patient safety during clinical trials with rigorous monitoring and strict adherence to protocols.
- Reduced project timelines for successful clinical trials by effectively managing resources and maintaining clear communication with stakeholders.
- Optimized resource allocation across multiple concurrent projects by utilizing advanced scheduling tools.
- Improved clinical trial efficiency by streamlining project management processes and implementing best practices.
- Implemented innovative strategies to improve patient recruitment and retention rates in clinical studies.
- Achieved timely completion of all assigned clinical projects while remaining within budget constraints.
- Regularly evaluated employee performance and provided feedback.
- Identified opportunities to improve clinical practices, devised strategies and implemented plans to increase patient care standards and enhance operational procedures.
Clinical Project Manager
Advenchen Laboratories, LLC
02.2021 - 11.2022
- Provide leadership and direction to CROs and clinical site management team members from start-up through to closure, also responsible for managing feasibility activities associated with the assigned clinical trials
- Serve as the Regulatory Manager and Safety Manager for assigned clinical trials
- Manage global investigational sites to ensure compliance with protocol and overall clinical objectives
- Develop Clinical Department SOPs, Study guidelines/ Plans and assist in the development of study related documents like Protocol, ICFs, study documents
- Oversee compliance to the Clinical Monitoring Plan, including site visits, review/ finalize visit reports, notate and report Protocol deviations as needed
- Train CRAs and PMs on implementation of study protocol EDC and Clinical operations SOPs
- When required, provide support to CRAs as a co-monitor at sites.
Clinical Project Coordinator
Medpace
09.2019 - 08.2020
- Provide day-to-day support to Clinical Trial Manager (CTM) and study team
- Set up and maintain project-specific ClinTrak module
- Support feasibility under leadership of CTM and Medical Monitor
- Support sites and Clinical Research Associates with site study supply distribution
- Provide oversight of electronic Trial Master File (TMF), including management and coordination of required TMF quality reviews
- Generate Study documents for Investigator Site Files (ISF) and presentation materials for Kick-Off meeting, Investigator meeting, and any other face-to-face Sponsor meetings
- Maintain close collaboration, interaction, and effective working relationships with Medpace and Sponsor project team members.
Clinical Research Associate
Consultant
02.2016 - 07.2018
- Conduct pre-study, initiation, monitoring, and close-out visits according to SOPs and GCP
- Responsible for overall site management for assigned sites including written and verbal communication and scheduling of monitoring visits
- Responsible for completion of visit reports and maintenance of study-related databases
- Responsible for Phase II and III Study Site management, and on-site monitoring for different indications trials
- Ensure subject safety and adverse event reporting to sponsor and IRB/IEC
- Perform investigative site file reconciliation and review and ensure Investigator Site Files (ISF) are accurate, current, and identical to Trial Master File (TMF).
Student Research/ Teaching Assistant
Louisiana Tech University
09.2013 - 08.2015
- Worked on creating a semi-natural hydrogel scaffold of Gelatin methacrylate that maintains long-term cellular viability and functionality and has the ability to induce cellular differentiation leading to complex tissue formation
- Created antibacterial and protein-repelling Halloysite nanotubes (HNTs) and polydimethylsiloxane (PDMS) composites which was presented in 2015 Frontiers in Polymer Science conference
- Completed daily reports on attendance and disciplinary performance
- Supported classroom activities, tutoring, and reviewing work
- Helped with grading assignments and tests, providing constructive feedback to students based on results.
Assistant Professor
G.D. Rungta College of Science and Technology
05.2011 - 07.2013
- Collaboratively taught Genetic Engineering, Biochemistry, Molecular Biology, and Recombinant DNA technology to both undergraduate and postgraduate courses
- Evaluated and supervised student activities and performance levels to provide reports on academic progress
- Helped struggling students by providing support outside of classrooms and consistently checking in on progress
- Applied innovative teaching methods to encourage student learning objectives
- Proctored exams and provided remediation for learning improvement goals
- Supported weekly Genetic Engineering, Biochemistry, Molecular Biology, and Recombinant DNA technology lab sessions, contributing to student engagement, comprehension, and learning objectives.
Education
Master of Science: Molecular Sciences and Nanotechnology -
Louisiana Tech University
Ruston, LA2015
Master of Science: Medical Genetics - Medical Genetics
MGM School of Biomedical Sciences, MGM University
Navi Mumbai, India2011
Bachelor of Science - Applied Genetics, Biochemistry And Microbiology
MS Ramaiah College of Arts, Sciences, And Commerce
India2009
Skills
- Trial Oversight
- Clinical trial management
- Operations Oversight
- Site monitoring
- Project Implementation
- FDA Compliance
- Project planning
- Vendor Management
Certification
- ACRP-CP® (ACRP Certified Professional)-The Association of Clinical Research Professionals
- DNA Fingerprinting certificate, Chhattisgarh State Forensic Laboratory - India
- Flow Cytometry certificate, JLN Medical College - India
- Marketing certificate, The Wharton School, University of Pennsylvania, online
- Healthcare Management certificate, eCornell, online
- Initiating and Planning Projects certificate, UCI Extension, online
- Budgeting and Scheduling Projects certificate, UCI Extension, online
- Managing Project Risks and Changes certificate, UCI Extension, online
- Analyzing Global Trends for Business and Society certificate, The Wharton School, University of Pennsylvania, online
- Inspiring Leadership Through Emotional Intelligence certificate, Case Western Reserve University, online
Affiliations
- Member of Association of Clinical Research Professionals (ACRP)
- The Society of Clinical Research Associates (SoCRA)
- Vice President, American Association of Information Technology Professionals (AAITP)
- Senior Member, Institute of Electrical and Electronics Engineers (IEEE)
Publications
Research Papers
- Factors Influencing Timely Initiation of Clinical Trials: An Analysis of Start-up Phase Delays
- Diversity, Equity, and Inclusion (DEI) in Clinical Trials
- Optimizing Clinical Trials Through Vendor Management
- Embracing the Future: Opportunities and Challenges of AI Integration in Healthcare
- Antibacterial and Protein Repelling Clay Nanotube-Silicone Composites
- A study to understand the relation between fetal hemoglobin, the hematological parameters and Xmn 1 gene polymorphism.
- Rapid One step DNA Extraction Method from (Gastrimargus Musicus) through Formaldehyde
- To Analyze the Water Sample of Pond Located Near Nandani Mines in Durg District Chhattisgarh, India
- Depression in Working Professionals – A Systematic Review of the
Awards and Accomplishments
Peer reviewed +50 Journal manuscripts for BMC Trials.
Awards:
- Globee Awards: Honored with Silver and Bronze Globee® Awards in 2023, including Women of the Year in Healthcare, Most Innovative Person of the Year in Healthcare & Biotech, and Thought Leadership in Healthcare and Wellness.
- Titan Health Awards: Recognized for Achievement of the Year
Media:
- Embracing Diversity And Inclusion In Clinical Trials - PharmaLive
- AML cell therapy trials to watch in 2024 targeting GvHD - Clinical Trials Arena
- Safety First: The Rigorous Protocols Protecting Clinical Trial Participants - usawire
- From Lab to Real-World: Navigating the Phases of Clinical Trials and Dispelling Myths - usawire
Timeline
Clinical Project Manager
Compass Pathways
11.2022 - Current
Clinical Project Manager
Advenchen Laboratories, LLC
02.2021 - 11.2022
Clinical Project Coordinator
Medpace
09.2019 - 08.2020
Clinical Research Associate
Consultant
02.2016 - 07.2018
Student Research/ Teaching Assistant
Louisiana Tech University
09.2013 - 08.2015
Assistant Professor
G.D. Rungta College of Science and Technology
05.2011 - 07.2013
- ACRP-CP® (ACRP Certified Professional)-The Association of Clinical Research Professionals
- DNA Fingerprinting certificate, Chhattisgarh State Forensic Laboratory - India
- Flow Cytometry certificate, JLN Medical College - India
- Marketing certificate, The Wharton School, University of Pennsylvania, online
- Healthcare Management certificate, eCornell, online
- Initiating and Planning Projects certificate, UCI Extension, online
- Budgeting and Scheduling Projects certificate, UCI Extension, online
- Managing Project Risks and Changes certificate, UCI Extension, online
- Analyzing Global Trends for Business and Society certificate, The Wharton School, University of Pennsylvania, online
- Inspiring Leadership Through Emotional Intelligence certificate, Case Western Reserve University, online
Master of Science: Molecular Sciences and Nanotechnology -
Louisiana Tech University
Master of Science: Medical Genetics - Medical Genetics
MGM School of Biomedical Sciences, MGM University
Bachelor of Science - Applied Genetics, Biochemistry And Microbiology
MS Ramaiah College of Arts, Sciences, And Commerce
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