Summary
Overview
Work History
Education
Skills
Core Domain Competencies
Timeline
Generic
Divita Tripathi

Divita Tripathi

Mumbai

Summary

Results-driven Clinical Operations Professional with 9 years in central-lab operations and monitoring. Delivered high compliance and quality control scores in global phase I-IV oncology, neurology, and dermatology trials. Specialised in site-visit report oversight, SAE management, and regulatory inspection readiness, while mentoring junior staff. Holds multiple GCP accreditations and received two internal awards for quality and productivity.

Overview

11
11
years of professional experience

Work History

Associate Centralized Monitoring Lead (Site Report Review Specialist)

IQVIA (incl. Q2 Solutions)
Mumbai
03.2023 - Current
  • Lead review of site visit reports against protocol annotations, SOPs and guidelines across multiple concurrent studies, escalating quality issues and trends directly to Clinical Leads.
  • Consistently deliver 95%+ compliance on Day-3 review turnaround and Day-10 approval, with QC scores above 95% on quarterly independent quality assessments.
  • Analysed study complexity to scope Estimate-at-Completion (EAC) hours and turnaround time, recommending and tracking corrective actions based on site performance.
  • Delivered CRA and centralized-monitoring training as Subject Matter Expert, identified team training needs, and authored monitoring annotations aligned with study timelines.
  • Mentored and coached junior Centralized Monitoring Services staff, ensuring project continuity through designated back-up support.

Senior Lab Central Project Coordinator

IQVIA (incl. Q2 Solutions)
Mumbai
07.2021 - 03.2023
  • Oversaw daily central-lab operations for global trials, ensuring effective specimen management, LIMS set-up, import permits, courier logistics, and kit shipment throughout study phases.
  • Collaborated with Lab, Lab Operations and Specimen Management teams to maintain schedule adherence; tracked overdue shipments, failed lab reports, and queue backlogs, escalating risks to Project Management to protect study timelines.
  • Developed detailed project documentation, including scope of work, project schedules, and financial reports.
  • Monitored staff performance and developed improvement plans.
  • Coordinated multi-disciplinary project teams, facilitating communication and resource allocation for timely project completion.

Clinical Process Specialist / Clinical Process Associate

IQVIA (incl. Q2 Solutions)
Mumbai
03.2017 - 07.2021
  • Received two WWD-Applause awards (2018) for delivering sustained quality and resolving high volumes of DCQ queries accurately.
  • Managed expiry-kit notifications, monitored Autofax/DCQ queries, and processed kit orders; closed studies by resolving outstanding issues and completing ELVIS documentation.
  • Promoted through two grades over four years for consistent delivery on central-lab monitoring across Phase I-IV trials in Oncology, Neurology, Dermatology, Immunology and other indications.

Clinical Process Associate I - Records Information Management

IQVIA (incl. Q2 Solutions)
Mumbai
08.2016 - 02.2017
  • Completed foundational GCP and role-specific training, supporting project execution and maintaining systems under supervision to ensure compliance and operational effectiveness.
  • Collaborated with team members to achieve target results.
  • Managed complaints with calm, clear communication and problem-solving.
  • Maintained clean, safe working environments to eliminate accident risks.

Clinical Research Coordinator

ACTREC, Tata Memorial Hospital
Mumbai
06.2015 - 04.2016
  • Maintained regulatory and study files for oncology research protocols, ensuring compliance with industry standards while liaising directly with sponsor representatives on study progress.
  • Reported Serious Adverse Events to Institutional Ethics Committee, sponsors, and regulatory authorities, upholding GCP requirements and contributing to participant safety and protocol integrity.
  • Managed regulatory documentation for clinical studies, adhering to Good Clinical Practice GCP and ethical guidelines.
  • Conducted informed consent processes with participants, clearly explaining study objectives and procedures.
  • Managed data entry and database maintenance, guaranteeing accuracy and security of participant information.

Education

P.G. Diploma - Clinical Research

Ramniranjan Jhunjhunwala College
India
01-2015

M.Sc. - Botany

K. J. Somaiya College of Science & Commerce
India
01-2015

B.Sc. - Life Science

Allahabad University
India
01-2013

Skills

  • Centralised monitoring
  • Site report management
  • Monitoring annotation development
  • Quality control management
  • Quality assurance management
  • Regulatory submissions
  • Trial management
  • Global project coordination
  • Multi-site management
  • Project management
  • Study oversight
  • CRA training delivery
  • Stakeholder management
  • Team mentoring
  • Junior coaching
  • Compliance oversight

Core Domain Competencies

Core Competencies: In-house Clinical Trial Monitoring (5+ Years) | Audit & Regulatory Inspection Support | Drug Accountability | International Project Management | Customer & Vendor Liaison | SAE Management | Query Resolution | Study File Maintenance | Clinical Documentation & Compliance

Timeline

Associate Centralized Monitoring Lead (Site Report Review Specialist)

IQVIA (incl. Q2 Solutions)
03.2023 - Current

Senior Lab Central Project Coordinator

IQVIA (incl. Q2 Solutions)
07.2021 - 03.2023

Clinical Process Specialist / Clinical Process Associate

IQVIA (incl. Q2 Solutions)
03.2017 - 07.2021

Clinical Process Associate I - Records Information Management

IQVIA (incl. Q2 Solutions)
08.2016 - 02.2017

Clinical Research Coordinator

ACTREC, Tata Memorial Hospital
06.2015 - 04.2016

P.G. Diploma - Clinical Research

Ramniranjan Jhunjhunwala College

M.Sc. - Botany

K. J. Somaiya College of Science & Commerce

B.Sc. - Life Science

Allahabad University
Divita Tripathi