Dhirendra Singh Parmar
Bengaluru
Summary
Dynamic data management professional with extensive experience, excelling in process optimization and risk mitigation. Proven track record in leading cross-functional teams to enhance operational efficiency and ensure data integrity. Adept at analytical thinking and clear communication, driving successful project outcomes in high-stakes environments.
Overview
16
16
years of professional experience
Work History
Manager-Data Management
GSK India Global Services Pvt Ltd
09.2021 - Current
- Overseeing the oncology portfolio as a Manager-Data Manager, handling multiple major priority projects.
- Led cross-functional teams to streamline operational processes and improve efficiency.
- Provided strategic vendor management, guaranteeing compliance with quality standards and risk reduction.
- Functioned as Subject Matter Expert for Local Lab Data, ensuring high-quality outputs.
- Supported training initiatives for campus hires entering Data Operations roles.
- Accountable for overall quality and delivery of DS&M activities related to electronic forms and assessments.
- Developed and implemented comprehensive data management strategies focused on data integrity.
- Led daily operational activities of in-house studies while being the primary DM point of contact.
- Oversee budget management and resource allocation for multiple projects simultaneously.
- Monitoring staff performance and addressing issues.
- Conducting regular meetings with staff to discuss progress and identify areas of improvement.
- Creating monthly reports for senior management summarizing operational performance metrics.
- Monitoring budgets and expenditures to ensure cost-effectiveness while maintaining quality standards.
Principal Clinical Data Manager
Novartis Healthcare Private Limited
09.2017 - 09.2021
- Company Overview: Novartis India Limited (NIL) is a subsidiary of Swiss giant Novartis, the world's second largest pharmaceutical company was incorporated on 13 December 1947. The Company is focused on the manufacturing and marketing of drugs, pharmaceutical products, and formulations for consumer healthcare and animal healthcare; it operates in four segments: Pharmaceuticals, Generics, Over the Trade Counter, and Animal Health.
- I worked as the Principal Clinical Data Manager.
- Was involved in developing and managing the clinical and health information system.
- I was responsible and accountable for managing all Data Management activities with respect to cost, quality and timelines for all assigned projects/trials within a Clinical Program.
- Responsible and accountable for managing all Data Management activities with respect to cost, quality and timelines for all assigned projects/trials within a Clinical Program.
- Was involved in developing and managing the clinical/ health information system.
- Ensure timely and quality development and validation of CRF’s and edits specifications for assigned studies/programs.
- Lead data management activities as Trial Data Manager for several studies or as a program Data Manager for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization.
- Provide and implement data management solutions; ensure knowledge sharing.
- Act as data management expert in problem-solving aspects.
- Key collaborator and strategic partner with stakeholders ensuring that data management activities for the clinical trials are executed efficiently with timely and high-quality deliverables.
- Provide active and effective communication to Clinical Trial Teams and other stakeholder groups.
- Co-ordinate activities of Data Managers either internally or externally.
- Take data management decisions and propose strategies at study or project level.
- Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical data management aspects (timelines, scope, resource plan), e.g. as DM representative in study- or project-level team.
- Review eCRF, discuss data structures and review activities, ensure project-level standardization which allows pooling and efficient CRT production.
- Comply with company, department and industry standards (e.g. CDISC) and processes.
- Assess the need for additional study specific CRF requirements across a program and influence increased standardization where possible.
- Responsible for quality control and audit readiness of all assigned data management deliverables, as well as the accuracy and reliability of the clinical database.
- Maintain up-to-date advanced knowledge of programming software (e.g. Jreview, as well as industry requirements (e.g.) CDISC SDTM/ADaM), attend functional meetings and trainings.
- Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance.
- Act as subject matter expert (SME) or, as assigned, lead process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures.
- Worked as a Program Data Manager (PDM) supporting multiple projects within different programs (molecules) in Oncology.
Clinical Data Analyst III
PAREXEL International (India) Pvt. Ltd.
06.2012 - 08.2017
- Company Overview: Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.
- I worked as Clinical Data Analyst III.
- I Worked as Study team lead for multiple projects with different indications and therapeutic areas like Type II Diabetes Mellitus, Breast Cancer, Lung Cancer, HIV infection, COPD etc. with huge patient population varying from 990 to 7376 subjects.
- I worked as a Study team lead managing Data Management activity in Data Operations supporting multiple projects from different Therapeutic area and different complexities.
- Assumes overall responsibility for the successful execution of the data management projects assigned.
- Provides leadership, supervision and train Data Management staff assigned throughout the trial for allocated trial activities.
- Prepare Data Cleaning Specification.
- Develop or provide input to project specific guidelines, e.g. SAE handling.
- Initiate the running of study specific programs.
- Utilize current study documentation including protocol, Case Report Forms (CRFs), cleaning guidelines etc.
- Conduct in-house data review.
- Generate and close queries or apply self-evident corrections to the data according to the relevant guidelines.
- Identify and report protocol violations.
- Manual and Patient Profile review, issue queries.
- Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action.
- Liaise with 3rd party vendors to clean electronic data.
- Ensure all documents coded for submission to central files.
- Update all relevant tracking system on an ongoing basis.
- Prioritizing the activities of DM task.
- Trial Set up activities including inputs to and review/perform of ‘Edit Check Specification writing and review, User Acceptance Testing (UAT) and functional QC of Total Data Extract (TDE).
- Provide professional DM input on Clinical Trial Team(s) to ensure high quality and consistent data.
- Monitors the progress of all data management activities for the project to ensure that project timelines are met.
- Directs activities associated with data integration and data.
- Monitors the quality and coordinates all data management QC activities for the project.
- Establishes and coordinates the timely completion of the database lock procedures.
- Delegates work to all the data analysts working on the project and coordinates with the project managers for resource allocation.
- Make project decisions at Data Management level and coordinate with other stakeholders.
- Understand the Protocol and other study specific documents to clean the data appropriately.
- Development of data validation specifications.
- Test data creation & UAT.
- Performing/ leading functional QC activities and testing.
- Create CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc.
- Data validation and cleaning.
- Conduct medical coding if assigned.
- Conduct SAE & third-party data reconciliations.
- Perform early and final database QC activities.
- Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.
Senior Process Associate
Tata Consultancy Services Limited (TCS)
01.2010 - 05.2012
- Company Overview: Tata Consultancy Services is an Indian multinational technology company that specializes in information technology services and consulting, headquartered in Mumbai, Maharashtra, India and has its largest workforce based in Chennai, Tamil Nadu, and India.
- I worked as a Senior Process Associate.
- I was involved in maintaining and updating the entire study files as per the requirement of the Protocol.
- I was involved in coordinating with the CDM study manager to understand the specific requirement of the study and receive the relevant tabs of the study file.
- Worked as a single point of contact for 5 projects.
- Review and understand the study Protocol and the timelines.
- Co-ordinate with the CDM study manager to understand the specific requirement of the study and receive the relevant tabs of the study file.
- To maintain and update the entire study files as per the requirement of the Protocol.
- To be aware and updated of the quality standards and undertake any relevant training for the same if required.
- Escalate any discrepancy in the Clinical Data to the CDM study manager.
- Action study team feedback as required on the data.
- Provide data listings in the required format as documented.
- Running external data reconciliation tools.
- Perform external checks to handle manual discrepancies and action the same.
- Review the resolved discrepancies and close where appropriate.
- Co-ordinate with the CDM study manager with respect to any unresolved queries and close the same.
- To ensure and error free, quality data with no open queries.
- Attend relevant study teleconference with the study team.
- Contacting the Monitor’s in case of any site issues/queries.
- Have regular teleconference with the Vendor’s to set the expectations for external data reconciliation.
- Getting connected with the counterpart for any updates or discussions.
- Preparing Study Close-out plans during the Timelines.
- Preparing weekly metrics of the study to know the study status and for the monitors to get connected with the site.
- Tata Consultancy Services is an Indian multinational technology company that specializes in information technology services and consulting, headquartered in Mumbai, Maharashtra, India and has its largest workforce based in Chennai, Tamil Nadu, and India.
Education
Base SAS 9 -
SAS Institute
01.2012
Post graduate diploma - Clinical Data Management
ICRI Mumbai
Mumbai01.2009
Bachelors - Homoeopathic Medicine and Surgery (alternative medicine)
Nagpur College of Homoeopathy
Maharashtra, India01.2006
Higher Secondary School -
Hislop College
Nagpur01.2001
SSC -
St. John’s High School
Nagpur01.1999
Skills
- Analytical thinking and problem resolution
- Data organization and analysis
- Process optimization
- Team collaboration across functions
- Risk evaluation and mitigation
- Clear communication skills
- Technical expertise
- Time prioritization
- Detail-oriented approach
References
- Abhijeet Sinkar, GSK India Global Services Pvt Ltd, Manager-Data Management, +91 9022296723, Abhijeet.x.arvindsinkar@gsk.com
- Amresh Kumar, Novartis Healthcare Private Limited, Senior Principal Clinical Data Manager (Functional Manager), +91 9642626144, amrshkumar@gmail.com
- Vivek Bodhale, PAREXEL International (India) Pvt. Ltd., Data operations lead (DOL), +91 8121182315, vivek.bodhale@gmail.com
- Vikrant Sawant, Tata consultancy services Limited (TCS), Business process lead, +91 9920940747, vikrant.sawant@gmail.com
Work Authorization
Australian PR visa-Skilled Nominated/190 (ACT Canberra), valid till 03Sep2030, Visa grant number: 0049563822367
Affiliations
Outside work, I engage in sports like badminton, cycling, walking and marathon.
Languages
English
First Language
English
Upper Intermediate (B2)
B2
Hindi
Intermediate (B1)
B1
Marathi
Beginner (A1)
A1
Accomplishments
Received multiple rewards and recognition for outstanding performance in complex projects
Timeline
Manager-Data Management
GSK India Global Services Pvt Ltd
09.2021 - Current
Principal Clinical Data Manager
Novartis Healthcare Private Limited
09.2017 - 09.2021
Clinical Data Analyst III
PAREXEL International (India) Pvt. Ltd.
06.2012 - 08.2017
Senior Process Associate
Tata Consultancy Services Limited (TCS)
01.2010 - 05.2012
Base SAS 9 -
SAS Institute
Post graduate diploma - Clinical Data Management
ICRI Mumbai
Bachelors - Homoeopathic Medicine and Surgery (alternative medicine)
Nagpur College of Homoeopathy
Higher Secondary School -
Hislop College
SSC -
St. John’s High School
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