Hi, I’m
Varun Pabolu
Sr Principal Clinical Data Manager
Bangalore
Summary
Experienced Clinical Data Manager with 13+ years driving evidence-based decisions and ensuring clinical trial success. Skilled in end-to-end data management, including collection, validation, cleaning, and reporting. Proficient in process improvement and implementing Corrective and Preventive Actions (CAPA) to enhance data integrity and compliance. Actively contribute to audit inspection readiness while maintaining a collaborative team player mindset. Committed to delivering efficient, high-quality data management practices and transforming data into actionable insights for healthcare advancement.
Overview
13
years of professional experience
2010
years of post-secondary education
1
Certification
Work History
Alcon
Sr Principal Clinical Data Manager
08.2021 - Current
Job overview
- Lead data management activities as PCDM for Refractive Portfolio and Vit-Ret Portfolio.
- Streamlined internal workflows by automating manual tasks, leading to reduced errors and increased efficiency.
- Delivered significant project outcomes by leading cross-functional teams in a cooperative setting.
- Ensures Third party and other necessary reconciliation activities are performed for the study promptly
- Provide and implement data management solutions, ensure knowledge sharing.
- Act as data management expert in problem-solving aspects
- Collaborated with stakeholders at various organizational levels to develop targeted strategies aligned with overarching business objectives.
- Created extensive embedded process maps, bringing in all the processes and templates in one place .
- Recognize and resolve protocol issues that may affect database design or analysis that do not make the best use of available standards
- Responsible and accountable to ensure consistency and maintain study documents in Document management system for assigned trials.
- Responsible for quality control and audit readiness of all assigned data management deliverables as well as accuracy and reliability of the clinical database
- Mentored junior team members, fostering their professional growth and supporting the development of future organizational leaders.
Novartis
Sr. Clinical Data Manager
04.2019 - 08.2021
Job overview
- Lead data management activities as Trial Data Manager for two Phase 3 Clinical Studies
- Performed DM activities for startup of a study including preparing the eCRF, CCG's, Edit Check Specifications, Data Handling plan (DHP), Data Quality Plan (DQP), Data Transfer Specifications, tSDV Specifications etc
- Performed User acceptance testing (UAT) and local lab set up, Query Management, and Data Review for Clinical Study
- Tracks and reports status and progress for assigned trials
- Proactively ensure milestones are met with quality (Snapshots and interim/final locks)
- Co-ordinate activities of Data Managers internally
- Make data management decisions and propose strategies at study level
- Build and maintain effective working relationship with cross-functional teams
- Disseminates study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)
- Able to summarize and discuss status of deliverables and critical data management aspects (timelines, scope, resource plan), e.g., as DM representative in CTT meetings
IQVIA
Associate Data Team Lead
09.2018 - 04.2019
Job overview
- Conduct comprehensive data management tasks including data review, writing, and resolving data clarifications, Perform / Coordinate/ validation and quality control activities of the database ensuring the integrity of the clinical trial
- Provide leadership and technical expertise for a specific DM Task or the DM team, Perform DB Design Activities
- Effectively implemented Corrective and Preventive Actions (CAPA) in response to audit findings, resulting in improved data management processes and compliance with regulatory requirements
- Manages Scope of Work (SOW) and/or budget, ensuring that services are met according to the SOW/ contract
- Serves as point of contact for customers on data management deliverables, ensuring open communications with the customer and IQVIA management to meet contractual obligations
- Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
- Meet with Data Operations team members to ensure milestones meet timelines and quality deliverables
- Create CRF, Edit Specifications, SAS Specifications and other relevant DMP Documents
- Ensures appropriate resources are assigned to meet project deliverables, Implement quality management Plans
- Serves as the escalation point for unresolved data issues collaborating with client data managers, vendors, and internal team members for resolution
- Created RASCI matrix, Dash Boards, Interactive Overdue Visit tracker, SOP completion checklist, across several Studies
IQVIA
Sr. Clinical Data Coordinator
07.2013 - 08.2018
Job overview
- Served as a DOC for several Studies coordinating with DTL, Coding team, Programmers and the resources assigned to the study
- Also serve as back-up for DTL during times
- Review edit specifications and prepare test plan for edit checks
- Perform quality checks on data reviewed by resources to ensure all work performed is of high quality following all internal and sponsor Sops
- Identifying of Clean Patients and Lock them on an ongoing basis
- Interact with CPM, CRAs to negotiate timelines and prepare newsletter for distributing to Sites during timelines
- Update Metrics daily and complete overall Bi-weekly metrics, have took the initiative to create page predictions tracker based on the expected visit dates for one of the paper study
- Ensure all data is in- there are no missing fields, missing signatures, SAE reconciled, all lab and any vendor data is received
- Perform Critical Data checks and review Data Handling Report
- Address the feedback received from BIOS (Stats)
ICON Clinical Research (P) Ltd
Associate Clinical Data Coordinator
06.2012 - 07.2013
Job overview
- Discrepancy Management, Freezing and Locking, Identification of Clean Patients, Manual Listings Review
- Ensuring the completeness, consistency and quality of the clinical trial data that has gone through data entry
- Understanding Protocol, eCRF Completion Guidelines, DVS, SOPs
- Communicate effectively with project team, Clinical data lead, Project manager
- Perform external data reconciliation (SAE, Lab, ECG) in accordance with all applicable procedures
- Generating weekly, monthly and status reports, also generate adjudication listings on Monthly basis
Avesthagen (P) Ltd
CDM Internee
09.2011 - 05.2012
Job overview
- Study build up / set up, Data entry, Discrepancy management, Edit Check specifications and DB UAT In OC
Education
Sheffield Hallam University
MS from Pharmacology and Biotechnology
University Overview
Successfully completed research project on The Role of Emodin on Leukemic Cell Lines; completed training as Lab Assistant from Sheffield Hallam University
Nagarjuna University (KLCE)
Bachelor of Technology from Biotechnology
University Overview
GPA: 1st Class
Skills
Clinical Data Management Tools-Expertise in tools like Medidata Rave, Oracle Clinical, Veeva Vault, EDC systems, and SAS
Programming and Data Analysis-Familiarity with Python and SQL for creating Automation Packages
Microsoft Office including Access to Automate Queries for cleaning clinical Data
Regulatory Knowledge-Understanding of GCP (Good Clinical Practice), ICH guidelines
Clinical Trial Knowledge-Strong understanding of the clinical trial lifecycle and protocol
Experience with managing Case Report Forms (CRFs) and query resolution
Data Standards-Familiarity in CDISC standards like SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model)
Data Quality Assurance-Experience with database testing, validation, and maintaining audit trails
Proficiency in ensuring data integrity through cleaning and reconciliation
Accomplishments
- SHU-Worked a leader for Poster Presentation and won the 2nd prize out of 23 projects in the department.
- Icon- Won 1st prize in Poster presentation for one of the protocol.
- IQVIA- Several Awards Received for showing Leadership Skills, Successful migration of 3 studies from Discovere to OC-RDC, Interim Analysis Locks and DB Locks.
- Novartis- Received Impact Award for achieving Team BIG BOLD Objective for 2020.
- Alcon- Received AGS Brilliance Award for leading a study with complex external data.
Therapeutic Areas Worked
- Neurology- Multiple Sclerosis
- Oncology- Solid Tumors and Lung Cancer
- Cardiovascular
- Metabolic Disorders- Anemia
- Musculo-Skeletal- Rheumatoid Arthritis and Lower Back Pain
- Ophthalmology
Certification
Certified ScrumMaster (CSM) - Scrum Alliance.
Timeline
Sr Principal Clinical Data Manager
Alcon
08.2021 - Current
Sr. Clinical Data Manager
Novartis
04.2019 - 08.2021
Associate Data Team Lead
IQVIA
09.2018 - 04.2019
Sr. Clinical Data Coordinator
IQVIA
07.2013 - 08.2018
Associate Clinical Data Coordinator
ICON Clinical Research (P) Ltd
06.2012 - 07.2013
CDM Internee
Avesthagen (P) Ltd
09.2011 - 05.2012
Nagarjuna University (KLCE)
Bachelor of Technology from Biotechnology
01.2009
Sheffield Hallam University
MS from Pharmacology and Biotechnology
01.2010