Summary
Overview
Work History
Education
Skills
Timeline
Generic

Ajay Kojhgiri

Bichkunad

Summary

Project Specialist with 4+ years of experience in clinical trial operations. Expertise includes 2 years as Associate Safety Specialist and 1 year 7 months as Associate Programmer. Proven ability to manage project timelines and ensure compliance with regulatory standards.

Overview

5
5
years of professional experience

Work History

Project Specialist-RTSM, Operations - GSS Project Support Services

Signant Health
Hyderabad
11.2023 - Current
  • Collaborated with internal clinical trial teams and sponsors to meet all FDA compliances and regulations. Managed project processes with multiple software tracking tools (JIRA, SQL, Adobe, AQT) and executed technical and clinical functions by the study protocol and according to standard operating procedures (SOPs).
  • Contributed to the successful execution of project tasks under the guidance of the Associate Project Manager and/or Project Manager. Effectively managed assigned responsibilities throughout the project lifecycle, ensuring timely and accurate completion.
  • Prepared and reviewed study manuals and guides.
  • Resolved reconciliation and data integration issues through retrigger activities.
  • Worked with different tickets from multiple ticketing systems (JSM, PITA, PI, DTPs) and forms (DCF, UCF, OCF).
  • Supported PM activities, including client-facing and non-client-facing communications.
  • Contributed to enhancements, UAT setups, and related documentation.
  • Coordinated with internal and external stakeholders to ensure smooth project activities.
  • Coordinated across all project phases, ensuring the project plan and deliverables met client expectations.
  • Multitasking, maintaining schedules, and maintaining compliance with quality deliverables in dynamic environments.
  • Collaborated with Global Project Management and Global Technical Delivery teams for timely project deliverables.
  • Oversaw development and approval of study materials, ensuring compliance with Quality Management standards.
  • Reviewed and monitored study status, risks, resources, and logistics to ensure alignment with the scope of services.
  • Have an overview of new Change Order creation and supporting Business Development operations.
  • Successfully executed all startup activities for RTSM (Randomization and Trial Supply Management) studies, ensuring readiness and compliance with study protocols and timelines.

Associate Programmer

Clinotica Software Solutions
Hyderabad
07.2022 - 11.2023
  • Gathered user requirements and performed data screening, cleaning, and integration to ensure accuracy and consistency.
  • Developed and validated SDTM datasets using SAS programming, including variable derivation based on annotated CRFs and mapping sheets.
  • Created project-specific macros and organized initial study folders to establish clear study hierarchies and workflows.
  • Utilized SAS/Base, PROC MEANS, PROC FREQ, and PROC REPORT for statistical analysis and report generation; leveraged SAS ODS for customized outputs in HTML, RTF, and PDF formats.
  • Ensured timely completion of assigned objectives, communicated project updates to team leads, and supported departmental reporting and collaboration efforts.

Associate Safety Specialist

PPD, part of Thermo Fisher Scientific
Hyderabad
09.2020 - 06.2022
  • Progressed from Initial Reviewer to Quality Reviewer (Sept 2020-Oct 2021) through internal job posting, demonstrating growth and adaptability.
  • Conducted literature screening to identify Individual Case Safety Reports (ICSRs) and other safety-related findings.
  • Reviewed case entries for quality, consistency, and accuracy, including peer report evaluations.
  • Managed receipt, tracking, and validation of ICSRs from various sources (post-marketing, clinical trials, literature) for database entry.
  • Performed detailed data entry of complex ICSRs, ensuring accurate coding using MedDRA and WHO drug dictionaries, and clear narrative summaries.
  • Coordinated the conduct of root cause analysis (RCA) and developed corrective and preventive actions (CAPA) for protocol deviations.
  • Executed self-quality checks prior to workflow progression, maintaining high standards of data integrity and compliance.

Education

Doctor Of Pharmacy -

Vaagdevi Institute of Pharmaceutical Sciences
01.2020

Skills

  • Clinical research and trial operations
  • Global project management
  • Regulatory compliance and data oversight
  • Team leadership and training
  • Time management and multitasking
  • Microsoft Office Suite proficiency
  • SAS programming
  • Statistical analysis

Timeline

Project Specialist-RTSM, Operations - GSS Project Support Services

Signant Health
11.2023 - Current

Associate Programmer

Clinotica Software Solutions
07.2022 - 11.2023

Associate Safety Specialist

PPD, part of Thermo Fisher Scientific
09.2020 - 06.2022

Doctor Of Pharmacy -

Vaagdevi Institute of Pharmaceutical Sciences
Ajay Kojhgiri