Shrey Dongre
Clinical Project Management
Thane
Summary
Result-driven professional with a proven track record in clinical project Management having 3 years experience in Clinical Operations and Study Maintenance. Expertise in Quality Assessment and Review of Clinical Brochures and Investigator Lab Manuals. Extensive experience in study start-up and study maintenance, Remote Site Monitoring and complete Clinical Trial Project maintenance of Phase 1-IV studies with a strong focus on delivering measurable outcomes. Demonstrated experience in handling Client requests and queries. Have been handling separate specialized inbox for client related queries and have successfully trained freshers and Peers. Adept at achieving high quality and quick resolution and dedicated to continuous professional development. Seeking to leverage skills and experience with continuous learning as primary goal towards career and the company.
Overview
3
3
years of professional experience
8
8
Certifications
Work History
Senior Clinical Project Coordinator
Labcorp Drug Development
06.2022 - 12.2023
- Supervised and managed daily activities of clinical project team consisting of support staff.
- Implemented new SOPs
- Coordinated, monitored, assigned, and documented patient and clinical care activities.
- Collected, evaluated, and modeled collected data.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Carrying in and out study maintenance Tasks from database loading to Sample Disposal for various Clinical Trial
- Projects.
- Monitoring Clinical sites and acting as POC for various Clinical Studies.
- Handling Sponsor' requests for kit orders to test ordering or cancellation.
- Closely monitoring for Alerts/Panics and adverse results across multiple sites.
- Maintaining TMF and patient safety data.
- Budget and billing support with Due Diligence activities
- Supporting Global study managers and Regional study managers in various activities.
- Project team representative working closely with internal and external stakeholders.
- Accurately records data management of current study documents, reporting using EDD, COGNOS, LIMS, Reflection, XIP, Lab link.
- Mentor, Trainer and QCer for team.
Clinical Publishing Coordinator
Labcorp Drug Development
12.2020 - 05.2022
- Worked as Investigator Manual and Case Report Form writer.
- Managed query inbox and served as POC for client /sponsor related queries and Lab Manual quality reviews
- Helped various global players in Clinical Research study, Clinical trials, and research Kit Supplies Requisitions form
- Liaised with internal Lab Manual Translation teams for manual translation and Laminated Synopsis generation.
- Supported study designs and preparation of SOWs/ Protocols procedures.
- Undertaken Training and mentoring responsibilities.
- Communicated with vendors to secure supplies and drive on-time completion of document reproduction.
- Participated in meetings and conference calls to gather and communicate document layout and production process information and represent production function.
- Recommended layout changes to make investigator brochure/ Lab Manuals more accessible and improve presentation.
- Interacted with sponsors and other internal teams to define requirements and resolve content, production and scheduling issues.
Education
MBA - Business Management (April 2024)
NMIMS
Mumbai 04.2001 -
Master of Science - Zoology
University of Mumbai
Mumbai 04.2001 -
P.G Diploma in Quality Management
NITMS,Nagpur
Thane05.2019
Bachelor of Science - Zoology
University of Mumbai
Mumbai 04.2001 -
Skills
Clinical Research
Stakeholder Communication
Protocol Development
Document Management
Clinical Quality Improvement
Clinical Documentation
Medical Records Management
Data Compilation
Microsoft Project
Adobe Workday
Monitoring
Veeva Systems
LEAN Sigma and Agile
Certification
ICH-GCP
Timeline
Senior Clinical Project Coordinator
Labcorp Drug Development
06.2022 - 12.2023
Clinical Publishing Coordinator
Labcorp Drug Development
12.2020 - 05.2022
MBA - Business Management (April 2024)
NMIMS
04.2001 -
Master of Science - Zoology
University of Mumbai
04.2001 -
Bachelor of Science - Zoology
University of Mumbai
04.2001 -
P.G Diploma in Quality Management
NITMS,Nagpur