Gouri Kamble
Implementation Services- Trial Design
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About
Looking for a challenging career which demands the best of my professional ability and also wants professional and personal growth along with organization.
Experience
Associate - Trial Design Implementation Services at Reify Healthcare: OnestudyTeam (2024-08 – Present)
Configured and implemented EDC and CTMS platforms to support protocol-driven global clinical trials. Led end-to-end Solutions Trial Design process with full lifecycle management.
- Configured and implemented EDC and CTMS platforms to support protocol-driven global clinical trials, ensuring compliance with GCP and regulatory standards.
- Led end-to-end Solutions Trial Design process, managing the full lifecycle from project kickoff, requirements gathering, and solution design through study conduct and go-live.
- Owned project execution across all phases, including system configuration, validation, User Acceptance Testing (UAT), and deployment for multi-country clinical studies.
- Partnered with global sponsors, CROs, and cross-functional stakeholders to optimize study design, improve operational efficiency, and accelerate trial timelines.
- Acted as a Subject Matter Expert (SME) for clinical data workflows and platform implementation, ensuring adherence to industry best practices and high-quality data standards.
- Translated complex clinical protocols into scalable digital configurations, enabling efficient execution of decentralized and hybrid clinical trials.
- Designed and configured complex visit schedules, study workflows, and protocol-specific logic within clinical platforms to support diverse therapeutic areas.
- Led and coordinated UAT cycles, defect tracking, and quality assurance processes to deliver compliant and production-ready solutions.
- Mapping clinical protocols into system-based solutions. Support Solutions Validation / QA for the configuration.
- Utilized Jira and other project management tools to track deliverables, manage risks, and coordinate cross-functional teams in a fast-paced, global environment.
- Recognized for bridging the gap between clinical operations and technology by delivering innovative, scalable solutions aligned with sponsor needs.
Assistant Manager - QA at Mprex Healthcare P. Ltd. (2023-09 – 2024-08)
Oversaw on-site and remote clinical monitoring, ensuring strict adherence to GCP and regulatory requirements. Managed Clinical Data Management tasks.
- Oversaw on-site and remote clinical monitoring, ensuring strict adherence to Good Clinical Practice (GCP) and regulatory requirements. Perform quality checks for the clinical studies.
- Managed Clinical Data Management (CDM) tasks using CTMS, including data reconciliation and source data verification (SDV) to uphold data integrity.
Clinical Research Co-ordinator at Clinical Research Organization (2022-01 – 2023-08)
Managed all essential study documents and coordinated site feasibility. Oversaw data management across multiple clinical trials.
- Managed all essential study documents (TMF, ISF), ensuring accuracy and regulatory compliance.
- Coordinated site feasibility, logistics, and initiation visits (SIVs) while managing communication with investigators.
- Oversaw data management across multiple clinical trials, including data reconciliation and query resolution.
- Conducted Site Initiation and Closeout Visits, and maintained quality control, quality standards of essential documents (TMF, ISF).
- Reviewed CRFs and data collection workflows to ensure accurate, user-friendly data capture.
- Supported data extraction, reporting, and data cleaning activities for ongoing monitoring and trial closeout.
Lab Technician at Jeevansakshi Pathology, Laboratory (2019-11 – 2022-01)
Collection, labelling of blood sample and analyzing test as per standard procedures.
- Collection, labelling of blood sample and analyzing the test as per standard procedures.
- Calibration of laboratory equipment's.
- Collection of specimen for Covid-19.
Lab Technician at Balaji Diagnostic Centre, Laboratory (2018-12 – 2019-10)
Blood sample collection and processing using laboratory equipment. Monitoring test and procedures.
- Blood sample collection and processing by using laboratory equipment's.
- Monitoring test and procedures. Communicate and coordinate with patients.
Education
PGD in Clinical Research, Clinical Data Management & Pharmacovigilance – Nobel Hospital and Research Centre (2021-07 – 2022-02)
B. Sc in Chemistry – Shivaji University, Kolhapur (2015 – 2018)
