Vikram Laha
Summary
Detail-oriented Clinical Operations Assistant with over four years of experience in clinical research. Expertise in FTQ checks, document quality maintenance, and eTMF management using Veeva Vault. Proven capabilities in preparing EC dossiers, coordinating site shipments, and supporting site start-up activities while ensuring compliance with ICH-GCP and FDA guidelines. Previous role as Clinical Research Coordinator involved direct support to Principal Investigators in study feasibility, patient visits, and regulatory documentation. Detail-oriented Clinical Operations Assistant with expertise in FTQ checks, document quality maintenance, and eTMF management using Veeva Vault. Ensured compliance with ICH-GCP and FDA guidelines while coordinating site shipments and supporting site start-up activities. Delivered timely preparation of EC dossiers and enhanced project communication through collaboration with cross-functional stakeholders.
Overview
4
4
years of professional experience
Work History
Clinical Operation Assistant
Parexel International Clinical Research
06.2025 - Current
- Perform FTQ checks to ensure document accuracy and proper maintenance, and upload documents to eTMF (Veeva Vault).
- Prepared EC dossier and ISF-PSF content for submission.
- Coordinated courier shipments of study documents to sites, vendors, and clients, ensuring timely delivery for project needs.
- Coordinate translations, process invoices/payments, and collect internal site-related documents.
- Coordinated with sites on site start-up activities to facilitate smooth initiation of studies.
- Collaborated with cross-functional stakeholders to streamline project delivery processes and enhance communication.
Clinical Trial Assistant
Lambda Therapeutic Research Ltd.
04.2023 - 05.2025
- Assist the Project Manager with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
- Spearheaded trial master file (TMF) maintenance for global clinical trials, ensuring compliance with ICH GCP and FDA guidelines.
- Conducted quality control checks of trial documents to ensure completeness and accuracy.
- Collaborated with project managers to ensure study documentation met audit readiness requirements.
- Assist the PM in the preparation, handling, distribution, filing, and archiving clinical documentation and reports according to the scope of work and standard operating procedures at Lambda.
- Responsible for timely disbursal of Investigator payments based on Invoices received from sites.
- Perform administrative duties including scheduling and organizing meetings, and shipping supplies.
- Prepare and distribute meeting agendas and minutes as required.
- Set-up, and maintain the trial master file and review trial master file contents.
- Manage study supply shipment and tracking (lab kits, Documents, IMP & Samples).
- Updates various study trackers assigned by the Project Manager.
- Maintenance of trial-related documents and files within the facility.
- Prepare sponsor meeting presentation and discuss with team leader and PM.
Clinical Research Coordinator
Fortis Escort Heart Institute
Delhi
01.2023 - 04.2023
- Assists the PI in study feasibility assessments in a timely manner.
- Coordinates with Principal Investigator, hospital administration, and IEC to help ensure clinical research progress.
- Assists Principal Investigator in assured that all key personnel or persons 'engaged' in the research project have met training requirements in accordance with GCP and NDCT rules.
- Collaborate with PI and institution to respond to any audit findings and implement approved recommendations.
- Collaborate with the PI and relevant departments to prepare a categorized budget and justifications. Confirms accuracy and completeness of budgeted costs.
- Attend investigator meetings as required or requested by the PI.
- Establishes and organizes study files, including but not limited to, site investigator file. Regulatory binders, study specific source documentation and other materials.
- Coordinates participant tests and procedures.
- Collects data as required by the protocol. Assures timely completion of Case Report Forms. Maintains study timelines.
- Assists the Principal Investigator in submitting accurate and timely close-out documents.
- Trial Indication Phases Role National/ Global Investigational Product
- TNBC III CTA Global Drug Olaparib
- Fasting & Fed (Solid Tumor) CTA National Drug
- Bone Metastatic IV CTA National Drug
- Schizophrenia III CRC Global Drug
- Diabetic IV CRC National Drug
- Covid Drug III CRC National Drug
Clinical Research Coordinator
ESIC Medical College and Hospital
03.2022 - 12.2022
- Assists the PI in study feasibility assessments in a timely manner.
- Coordinates with Principal Investigator, hospital administration, and IEC to help ensure clinical research progress.
- Assists Principal Investigator in assured that all key personnel or persons 'engaged' in the research project have met training requirements in accordance with GCP and NDCT rules.
- Collaborate with PI and institution to respond to any audit findings and implement approved recommendations.
- Collaborate with the PI and relevant departments to prepare a categorized budget and justifications. Confirms accuracy and completeness of budgeted costs.
- Attend investigator meetings as required or requested by the PI.
- Establishes and organizes study files, including but not limited to, site investigator file. Regulatory binders, study specific source documentation and other materials.
- Coordinates participant tests and procedures.
- Collects data as required by the protocol. Assures timely completion of Case Report Forms. Maintains study timelines.
- Assists the Principal Investigator in submitting accurate and timely close-out documents.
Education
PG Diploma - Advanced Clinical Research and Pharmacovigilance
Institution of Clinical Research
Delhi, IndiaBachelor of Science - Chemistry
Lingaya's University
Faridabad, Haryana, IndiaSkills
- ETMF (VV) & CTMS Management
- Problem-solving skills
- Project planning
- Follow-up
- Tracking
- Attention to details
- Time management
- Collaboration
- Document Management
- Site Support
- Cross-functional collaboration
Custom
I, Vikram Laha, hereby declare that the information furnished above is correct and the best of my knowledge of my belief.
Timeline
Clinical Operation Assistant
Parexel International Clinical Research
06.2025 - Current
Clinical Trial Assistant
Lambda Therapeutic Research Ltd.
04.2023 - 05.2025
Clinical Research Coordinator
Fortis Escort Heart Institute
01.2023 - 04.2023
Clinical Research Coordinator
ESIC Medical College and Hospital
03.2022 - 12.2022
PG Diploma - Advanced Clinical Research and Pharmacovigilance
Institution of Clinical Research
Bachelor of Science - Chemistry
Lingaya's University