Avinash Vijaykumar Deshinge
Kolhapur
Summary
Skilled Validation Analyst with background in pharmaceutical and biotechnology industries. Experienced in performing process validation, equipment qualification, cleaning validation, and computer systems validation in compliance with regulatory standards. Brings strong problem-solving skills, analytical capabilities, and understanding of regulations including FDA guidelines, GxP requirements, and ISO standards. Proven track record in identifying potential issues, maintaining quality control and ensuring operational effectiveness.
Overview
12
12
years of professional experience
Work History
Validation Analyst
Fortrea
03.2022 - Current
- Maintaining Issue log
- Resolve the issues discussing with LEDC and LDM
- Performing data validation / UAT
- Database UAT
- Creating SAS test data validation Document and performing SAS Report UAT
- Creating Edit Check Scripting
- Creating Dynamic Scripting
- Creating Screen Flow Scripting
- Performing Edit Check Validation
- Performing Dynamic Validation
- Performing Screen Flow Validation
- Quality Review
Clinical Data Specialist
IQVIA
12.2019 - 03.2022
- Serve as a clinical data specialist and deals with CDM activity.
- Creating SAS specification Document and performing SAS Report UAT
- Creating e CRF completion guideline
- Creating DMP document
- Creating SAE reconciliation Document
- Providing Training to the fellow associate’s on UAT, CDM Reconciliation
- Query Management.
- Supporting start-up activity whenever require such as performing validation.
- Supporting LDM in study Close out activity and ensure all data cleaning activity
- Understand and comply with core operating procedures and working instructions.
- Develop and maintain good communications and working relationships with CDM team.
Clinical Data Manager (BPO3)
Tata Consultancy Services
05.2018 - 12.2019
- Maintains full understanding of protocol including study documentation.
- Preparation of Protocol Deviation Document.
- Drafting e-CRF completion guidelines.
- Writing DVR specifications and writing Test step.
- Performing discrepancy management in accordance with the agreed timelines.
- Reviewing all protocol Deviations
- Performing SAE reconciliation.
- Performing Vendor data reconciliation
- Executing data listings programs and dataset reviews for patient data consistency, Quality and completeness.
- Perform discrepancy management on front end checks and the programmed consistency checks(back end)
- To ensure error free, quality data with no open queries prior to database lock.
- Coordinates with the LDM with respect to any unresolved queries and close the same
- Efficacy analysis and database closures.
- Performing Data base lock and freezing.
- Coordinate with coding team for coding related activities.
- Supporting CDM in developing Study Metrics and Study Status Reporting.
Clinical Data Manager
Cognizant Technology solutions
07.2016 - 05.2018
- Define the data validation plan.
- Maintain the integrity of data, data systems, projects requiring data harvest ensuring timely, relevant, accurate and consistent information use.
- Customized database design screen test and development
- Edit validation and designing check and UAT
- Data Validation
- Data Cleaning
- Discrepancy Management (Managed and integrated all query responses into clinical databases).
- Data Reviewing (Ongoing QC)
- Third party data reconciliation
- Perform safety data reconciliation using the safety and clinical listings.
- Accountable for the quality and timelines of safety data management team deliverables
- Ensure timeline submission of timesheet/ functional tracking spread sheet.
Senior Clinical Research Associate (Monitor)
Target Institute of Medical Education and Research
06.2014 - 07.2016
- Worked on phase 2& phase 3 studies (endocrinology – Diabetes, Dyslipidemia, Liver Disorder, Kidney Stone, Immunity Based Studies, Pediatrics Study (Topical Application), Dermatological Study-Hair Fall
- Organizing and handling the Investigator meetings.
- Define clinical study timelines and workflow
- Give the training to the Site personal about protocol and GCP
- Developing and writing trial protocols (outlining the purpose and methodology of a trial);
- Designing data collection forms, known as case report forms (CRFs);
- Identifying and assessing the suitability of facilities to be used as the clinical trial site;
- Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site.
- Initiate the clinical study instance in the Clinical Data Management System
- Setting up the trial sites, which includes ensuring each center has the trial materials, including the trial drug often known as the investigational medicinal product. Plus training the site staff to trial-specific industry standards;
- Monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis;
- Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV);
- Collecting completed CRFs from hospitals and general practices;
- Writing visit reports and filing and collating trial documentation and reports;
- Ensuring all unused trial supplies are accounted.
- Preparing final reports and occasionally manuscripts for publication.
- Define clinical study timelines and workflow
- Interact with sponsor and clinical sites
- Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects;
- Closing down trial sites on completion of the trial
Education
M.SC. - Pharmaceutical Medicine
UDIRT
MUHS Nashik01.2015
MSc. - Zoology
Shivaji University
Kolhapur01.2012
BSc. - Zoology
Shivaji University
Kolhapur01.2010
BSc. - Chemistry
Shivaji University
Kolhapur01.2009
Laboratory Management with Food Analysis -
Shivaji University
Kolhapur01.2009
Skills
- OC RDC
- INFORM
- RAVE
- IBM
- DSG
- Clinion
- MS Office
Disclaimer
I hereby declare that the above particulars are true to the best of my knowledge & belief.
Personal Information
- Date of Birth: 07/24/88
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Languages
- Hindi
- Marathi
- English
- Hindi
- Marathi
Timeline
Validation Analyst
Fortrea
03.2022 - Current
Clinical Data Specialist
IQVIA
12.2019 - 03.2022
Clinical Data Manager (BPO3)
Tata Consultancy Services
05.2018 - 12.2019
Clinical Data Manager
Cognizant Technology solutions
07.2016 - 05.2018
Senior Clinical Research Associate (Monitor)
Target Institute of Medical Education and Research
06.2014 - 07.2016
M.SC. - Pharmaceutical Medicine
UDIRT
MSc. - Zoology
Shivaji University
BSc. - Zoology
Shivaji University
BSc. - Chemistry
Shivaji University
Laboratory Management with Food Analysis -
Shivaji University