Meet Darji
Gandhinagar
Summary
Dynamic Clinical Research Professional with over four years of experience in Biosimilars, clinical trial management, and project management within a Contract Research Organization (CRO). Expertise includes feasibility assessments, proposal development, regulatory coordination, and delivering client-facing projects with precision. Proven track record in managing late-phase clinical trials while collaborating effectively with cross-functional teams and leveraging CRM systems such as Microsoft Dynamics 365. Skilled in navigating project deliverables, ensuring compliance, and consistently surpassing client expectations.
Overview
4
4
years of professional experience
1
1
Certification
3
3
Languages
Work History
Senior Officer – Project Management (Business Development)
Lambda Therapeutic Research Ltd.
01.2025 - Current
- Appointed as a SPOC (single point of contact) for late-phase clinical trial.
- Prepared and shared project charters, tracked milestones, and assisted with regulatory filings.
- Identified and addressed risks in ongoing studies through collaboration with internal departments and sponsors.
- Ensured project deliverables met agreed terms, escalating issues for timely resolution.
- Liaised with the contracts and proposals team to finalize quotes and agreements based on client requirements.
- Managed a centralized tracker for invoice requests in late-phase studies, coordinating with finance and PM teams.
- Conducted late-phase feasibility assessments for external RFPs, alongside internal stakeholders.
- Oversaw pre-study activities for clinical trial projects, supporting execution phases.
- Served as the point of contact for TMF and CTMS concerns across global programs.
- Negotiated contracts with vendors to secure favorable terms, resulting in significant cost savings for the company.
- Increased team efficiency by streamlining communication and implementing new project management strategies.
Clinical Trial Assistant
Lambda Therapeutic Research Ltd.
04.2022 - 12.2024
- Supported project managers in maintaining clinical systems (CTMS, IWRS, BizNET, eTMF) to monitor site compliance, performance, and project timelines.
- Handled preparation, filing, and archiving of clinical documentation, ensuring timely updates to Trial Master Files (TMF/eTMF), and Site Master Files.
- Coordinated timely disbursement of investigator payments based on invoice tracking and site submissions.
- Tracked and managed Case Report Forms (CRFs), addressed data queries, and ensured the resolution of discrepancies to maintain data integrity.
- Acted as the central liaison for clinical teams, principal investigators, sites, and ethics committees to support regulatory submissions and site communication.
- Maintained study trackers, and ensured proper documentation archiving to support audit readiness.
- Supported study start-up activities, including document collection, Ethics Committee submissions, and site visit coordination (SSV, SIV, SMV, SCOV).
- Assisted in preparing QA and regulatory submission documents, ensuring compliance with ICH-GCP, SOPs, and sponsor requirements.
- Organized internal and external meetings, documented minutes, and tracked follow-up actions.
- Provided basic training to site staff on trial documentation and clinical data systems.
- Conducted system qualification tests for in-house tools, like IWRS and BizNET (EDC), ensuring software compliance with protocol needs.
Research Associate – Bioanalytical-Biosimilars
Lambda Therapeutic Research Ltd.
08.2021 - 03.2022
- Executed bioanalytical method development and validation, ensuring compliance with scientific and regulatory standards.
- Conducted sample analyses for preclinical and clinical studies, adhering to established method SOPs.
- Oversaw method validation and study sample analyses, maintaining accurate and contemporaneous data records.
- Facilitated root cause analysis for non-conformities, implementing corrective measures to ensure compliance.
- Supported the reconciliation of raw data from studies and method validations, ensuring data integrity.
- Managed scanning, archiving, and organization of project data for regulatory compliance, and future access.
- Coordinated inventory management for critical reagents and materials to support project requirements.
- Administered material receiving, logging, and distribution, with proper documentation and labeling.
EE Support – Research Intern
Teksun Microsys Pvt. Ltd.
03.2021 - 08.2021
- Collaborated with the product development team (sponsor) to effectively operate and manage a device for ingredient analysis, ensuring the correct usage of its parts and functionalities.
- Assisted in preparing and formulating solutions based on sponsor-provided ingredients, ensuring precision and accuracy in the analysis process.
- Utilized the data analysis system to generate, process, and interpret data, collaborating closely with colleagues to ensure accurate data collection and integrity.
- Created visual data representations, assisting in the plotting and presentation of analysis results, ensuring clarity and ease of understanding for stakeholders.
- Compiled detailed and comprehensive reports on data findings, preparing them for sponsor review, and ensuring the presentation of actionable insights.
- Actively participated in sponsor calls, presenting findings and analysis to clients, and addressing queries regarding data results and methodology.
- Supported cross-functional teams in improving the device's and software functionality, and contributed to the ongoing optimization of the analysis process.
- Ensured adherence to project timelines and quality standards, contributing to successful project milestones, and client satisfaction.
Education
Master of Science - Microbiology
Kadi Sarva Vishwavidyalaya
Gandhinagar, India07.2021
Bachelor of Science - Microbiology
Government Science College
Gandhinagar, India05.2019
Skills
Experience with project management software and CRM systems
Certification
GCP certified by NIDA Clinical Trials Network
Awards
Winner of ‘Best Acting’ award in theater state competitions (twice)
Timeline
Senior Officer – Project Management (Business Development)
Lambda Therapeutic Research Ltd.
01.2025 - Current
Clinical Trial Assistant
Lambda Therapeutic Research Ltd.
04.2022 - 12.2024
Research Associate – Bioanalytical-Biosimilars
Lambda Therapeutic Research Ltd.
08.2021 - 03.2022
EE Support – Research Intern
Teksun Microsys Pvt. Ltd.
03.2021 - 08.2021
Master of Science - Microbiology
Kadi Sarva Vishwavidyalaya
Bachelor of Science - Microbiology
Government Science College
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