Suraj Babar
Thane,MH
Summary
Experienced Clinical Research Assistant Manager with 10 years of progressive experience in Clinical Operations, Quality Assurance, Regulatory Compliance, Site Monitoring, Quality Control, Project Management, and Medical Writing & Regulatory Affairs. Dedicated professional committed to upholding high standards of quality for organizational advancement and increased profitability.
Overview
10
10
years of professional experience
Work History
Assistant Manager
Raptim Research Pvt. Ltd.
04.2024 - Current
- Responsible to Organize and plan team meeting to discuss about project logistics, assign duties, address concerns and troubleshoot problems.
- Sponsor/ Regulatory Query response.
- Application of BENOC and TL through SUGAM and NSWS portal.
- Handling IMP related details.
- To carry out QC checks of various documents of Clinical Trial/ BA-BE studies as per SOPs, Protocols and Regulatory requirements.
- Supporting in SOP preparation, revision and review procedure for Clinical development and implementation procedure.
- Review report on Adverse Events (AE), Serious Adverse Events (SAE).
- Preparation and Review of Clinical Study Protocols, ICD, CRFs, CSRs, Summary Tables, CDSIC datasets.
Senior Executive - Technical Documentation (Medical Writing/ Regulatory Affairs)
RAPTIM RESEARCH PVT. LTD.
04.2022 - 03.2024
- Preparation and Review of Clinical Study Protocols, ICD, CRFs, CSRs.
- Preparation and Review of all the additional documents required in line with Regulatory requirements. (DBE tables, Module 2.7.1, CSBE, BTIF etc.).
- Preparation and Review of CDISC data.
- Preparation and Review of eCTD data.
- Responsible to Organize and plan team meeting to discuss about project logistics, assign duties, address concerns and troubleshoot problems.
- To carry out QC checks of various documents of Clinical Trial/ BA-BE studies as per SOPs and Protocols and Report.
- Supporting software development team for eCRF software development, validation process (IQ, OQ, PQ) and implementation.
- Supporting in SOP preparation, revision and review procedure for Clinical development and implementation procedure.
- Review report on Adverse Events (AE), Serious Adverse Events (SAE).
- Sponsor/ Regulatory Query response.
Executive - Technical Documentation (Medical Writing/ Regulatory Affairs)
RAPTIM RESEARCH PVT. LTD.
01.2021 - 03.2022
- Responsible for generation and review of high level quality documents as described below:
- Preparation and Review of Clinical Study Protocol.
- Preparation and Review of Informed Consent Documents (ICD).
- Preparation and Review of Case Record Form (CRF).
- Preparation and Review of Clinical Study Report (CSR).
- Preparation and Review of Dossier.
- Preparation and Review of DBE Table (USFDA), Module 2.7 (EMA), CSBE (Canada), BTIF (WHO) as per Regulatory requirements.
- Sponsor/ Regulatory Query response.
Executive - Quality Assurance
RAPTIM RESEARCH PVT. LTD.
06.2019 - 01.2021
- Represents QA and provides QA Guidance for Project/ Study Teams with participation in applicable forums, providing GCP compliance input and guidance to achieve continuous Quality improvement.
- Ensured appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects.
- Participated in the development of the GCP risk assessment and identification of areas to be audited.
- Conducted QA Audits (Investigator Site, Vendor, Internal Process, For-Cause and directed/ complex Audits), generated Audit Reports, communicated results to relevant QA Management and interacted with various teams to ensure Corrective and Preventive actions (CAPA) are taken to bring QA observations to closure as applicable.
- Participated in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency.
- Provided GCP Training, Mock Inspection preparation and support as needed.
- Promoted GCP compliance across the organization to meet appropriate organization and department goals.
Officer - Quality Assurance
RAPTIM RESEARCH PVT. LTD.
01.2017 - 06.2019
- Project Specific Audit Plan Preparation and finalization in coordination with operations.
- Preparation of Audit tools based on Protocol, ICH-GCP, Regulatory Guidelines and relevant SOPs.
- Preparation of Audit Reports.
- Preparation of SOPs/ Work Instructions of QA and assisting in preparation of SOPs/ Work Instructions of other departments.
- Maintenance of QA Files and Audit tracking logs.
- Coordinating CAPA for important observations and providing training as a part of it.
- Responsible for internal arrangements for Sponsors and Regulatory Auditors (in coordination with Project Management/ Business Development personnel).
- Conducting In Process Audit of Informed Consent Process/ Documentation, Dosing Activity, Blood Sampling and Processing Activity, Vital Sign Measurement Activity.
- Conducting Retrospective Audits of all the Study related documents.
- Ensuring IQ, OQ and PQ are in place for all the equipments as a part of System Audits.
- Conducting Site Evaluation Visit.
Clinical Process Associate-2 - Site Management
IQVIA (QUINTILES IMS)
09.2016 - 12.2016
- Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines.
- Establish and maintain effective project/ site communications.
- Create and maintain relevant project documents Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information.
- Participate in document management (creation, review, maintenance, storage, as applicable).
Research Associate - QAU
ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD.
07.2015 - 09.2016
- In-Process Monitoring of all the Bioequivalence and Bioavailability Study conducted.
- Retrospective Review of all the Study related documents.
- Maintaining QA Audit Files, Generating Audit Reports, Closure of Audit Reports.
- Reviewing Calibration Certificates of Equipments and Instruments used in Clinical Studies.
- Providing support to team members during Sponsor based audits or Regulatory Inspections.
Education
Clinical SAS Programming -
Cytel
11.2018
Master of Pharmacy - undefined
Shivaji University
Kolhapur, MH09.2015
PG - Drug Regulatory Affairs
IPM
08.2015
Bachelor of Pharmacy - undefined
Shivaji University
Kolhapur, MH07.2013
Skills
- Experienced with Microsoft Office applications
- Skilled in Word processing
- Excel spreadsheet management
- Skilled in online platforms
- Project management coordination
- Project execution management
- Initiative-driven
- Effective communicator
Accomplishments
- Outstanding Alumina for the Year 2015 from Pharmacy College.
- Star Performer of the Year 2018 from QA department.
- Successfully faced and handled DCGI, US FDA, UK MHRA, WHO, EMA (BfArM & HPRA), GCC, Kazakh MOH and NPRA Regulatory Inspections.
Disclaimer
I hereby declare that the information provided here is accurate, correct and to the best of my knowledge.
Timeline
Assistant Manager
Raptim Research Pvt. Ltd.
04.2024 - Current
Senior Executive - Technical Documentation (Medical Writing/ Regulatory Affairs)
RAPTIM RESEARCH PVT. LTD.
04.2022 - 03.2024
Executive - Technical Documentation (Medical Writing/ Regulatory Affairs)
RAPTIM RESEARCH PVT. LTD.
01.2021 - 03.2022
Executive - Quality Assurance
RAPTIM RESEARCH PVT. LTD.
06.2019 - 01.2021
Officer - Quality Assurance
RAPTIM RESEARCH PVT. LTD.
01.2017 - 06.2019
Clinical Process Associate-2 - Site Management
IQVIA (QUINTILES IMS)
09.2016 - 12.2016
Research Associate - QAU
ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD.
07.2015 - 09.2016
Master of Pharmacy - undefined
Shivaji University
PG - Drug Regulatory Affairs
IPM
Bachelor of Pharmacy - undefined
Shivaji University
Clinical SAS Programming -
Cytel
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