Summary
Overview
Work History
Education
Skills
Certification
Interests
Achievements and Awards
Declaration
Timeline
Generic
Vaibhav Kulkarni

Vaibhav Kulkarni

Implementation Consultant
Pune

Summary

Clinical data management professional with 15 + years of experience and expertise in Medidata Rave, eCOA, and patient-centric technologies. Skilled in implementing and consulting on wide range of Rave products. Proven ability to deliver efficient study builds, system integrations, and client enablement.

Overview

17
17
years of professional experience
2
2
Certifications
1
1
Language

Work History

Manager, Implementation Consultant

Dassault Systems
08.2022 - Current
  • Lead configuration or enable customers on Medidata software to translate customer needs and meet customer requirements.
  • Adhere to or educate on best practices for implementing Medidata’s software
  • Offer client training services via on-site and online interaction to streamline onboarding process for newly implemented systems.
  • Author, adapt, or agree on specifications based upon client requirements. This can include functional test cases for use in configuring and developing solutions in Medidata’s suite of products, as well as in custom integrations.
  • Support developers and other cross functional departments during configuration or implementation of specifications
  • Advise study teams on optimal approaches for implementing eCOA to ensure compliance and usability.
  • Delivery of in-person/remote client workshops on eCOA, cloud admin and any other module as per client requirement.
  • Work on project management timelines and budgets, ensuring timely completion of deliverables within the agreed scope of work.
  • Support customers during enablement or implementation of our software by answering questions, resolving configuration or UAT issues, and providing guidance on software usage.
  • Adhere to industry data collection and handling standards to ensure consistency and facilitate downstream processing (e.g., QC testing).
  • Communicate status reports to stakeholders on both client and internal projects.
  • Participate in and lead internal initiatives, e.g., process improvement, product improvement, and identifying best practices.
  • Comply with and enforce Medidata Standard Operating Procedures, processes and policies.
  • Assist in the resource planning of professional services resources and liaise with technical services team to ensure timely completion of deliverables.
  • Support Training Group in preparation of course materials and delivery of courses both internally and externally as needed.
  • Support third party vendors with integration and/or data transfer efforts.
  • Own multiple customer-facing projects or engagements.
  • Significant knowledge and experience in one product or solution, or, relevant experience in a group of products/solutions.
  • Provide support to the customers during Rave enablement, URL upgrade, Study transfers and product enhancement releases.
  • Work with ICE team to prepare clinet facing documents on knowledge hub.
  • Mentor/Train AICs or new joinees.

Principal Database Architect

Inference Clinical Research
05.2021 - 08.2022
  • Lead study design projects within CDMS system using Medidata Rave and Medrio applications, leading clinical database programming activities
  • Review specification document created by study team such as DVS, eCRF specification and provide inputs to the team in order to build the studies with efficient design
  • Plan and execute edit check activities including any special actions/functions as per DVS.
  • Trouble shoot the study design issues and suggest the best possible solution.
  • Participate in study team meetings as an ad hoc study team member to advice study team on best approach/tool for data collection, to determine scope and limitation of the study.
  • Ensure quality is maintained in systems with proper documentation
  • Participate in data management activities and share the knowledge and provide latest updates/features.

Assistant Manager

Tata Consultancy Services
07.2013 - 05.2021
  • Assist leadership team in programming operations and provide inputs.
  • Perform quality control procedures for relevant activities.
  • Assist in developing and implementing new technology in database design
  • Liaise with application support team and client for any technical issues
  • Review quality and provide feedback to Data management and CDP teams
  • Conduct Rave study build training sessions for new joiners.
  • Make the teams ready for internal and external audits.
  • Initiate and perform comprehensive programming tasks pertaining to Database design, validation and data transfers in data management.
  • Assist in developing and implementing new technology in database design
  • Review the contract, protocol and other client specification
  • Review and provide feedback to specification documents and program edit checks as per specifications.
  • Adhere to SOPs/Regulatory requirements/project specific guidelines
  • Liaise with Medidata account manager and resolve the issue related to support tickets.
  • Keep the track and follow up for L2 support tickets related to Medidata issues in JIRA
  • Prepare FRA document in conjunction with client for upcoming patch upgarde or software releases and perform testing before prodcution release.
  • Perform SAT of URL after patch upgrade and write the test cases for testing referring Medidata release notes.
  • Update and maintain global library volumes as per client feedback and requirement
  • Share the knowledge and experience to train the other team members

Clinical Data Programmer

Theorem Clinical Research
07.2012 - 07.2013
  • Build eForms in Rave as per client specifications
  • Programming of edit checks in Rave.
  • Assist data mangers with status reports and listings as necessary.
  • Develop project specific procedure for loading external data and/or transferring internal data and verifying the process.
  • Ensure client specifications for data transfers are met.
  • Ensure client specifications for dictionary loading/coded data transfer are addressed.
  • Perform eCRF Migration activities as per change requests.

Programmer Analyst

Cognizant Technological Solutions India Pvt. Ltd.
06.2010 - 06.2012
  • To review the Data validation specification (DVS), Data standard document (DSD), Visit matrix and other document for clarity and to ensure their consistency based on e-CRF design and protocol requirement and provide feedback to Data managers.
  • Build unique and expanded CRF as per specifications in Rave tool.
  • Implement standard library checks to meet DVS specifications.
  • Build new study specific checks to as per study team requirement.
  • Perform developer level testing of DVS checks implemented
  • Receive and implement feedback on eCRF design as well as edit checks.
  • Co-ordinate all the activities with study team as well as different internal teams including onshore teams with appropriate communication.
  • To assign rights & roles for user acceptance testing.
  • Update e CRF/ checks based on the feedback from the study team after user acceptance testing.
  • Updating of changes in eCRF and amendments.
  • Compliance to internal tracking system on daily basis (Study level and fractal).

Adverse Event Case Processor

Cognizant Technological Solutions India Pvt. Ltd.
12.2009 - 06.2010
  • Assess the validity of adverse event case and process it in safety database using applications like Argus, eCTD, GDMS etc
  • Check the consistency of case against the source document and entering any data found relevant during assessment
  • Code the events, indications and patient history based on MedDRA
  • Code the suspect products as well as concomitant medications
  • Amend the narrative when required
  • Perform Labelling of events
  • Generate follow up information if required

Lecturer

Jayawant Institute of Pharmacy
10.2008 - 11.2009
  • Academic monitoring in charge for the year 2008-09.
  • To conduct the lectures for Bio-chemistry and Pharmaceutical Jurisprudence for Diploma pharmacy students.
  • To maintain the documentation as per MSBTE and AICTE norms.

Education

PG Diploma - Clinical Research and Regulatory affairs

Academy For Clinical Excellence
Mumbai
1 2010

Bachelor of Pharmacy -

Modern College of Pharmacy
Pune, India
1 2008

Skills

  • Technical Skills:
  • Medidata : iMedidata, Rave Architect, Medidata Designer, Medidata Patient Cloud, myMedidata, Core Configuration, Cloud Admin, iMedidata, eCOA/ePRO integrations, Site Admin, User Admin, Lab Administration, Report Administration, Amendment Manager, Publish Check, Batch Uploader, Translation Workbench, TSDV, Coder
  • Other EDC tools: AMOS, Medrio R41
  • Safety Database: Argus 42
  • Other Applications: BCE, JIRA, COGNOS, GMAT, DMP
  • Leadership skills:
  • Resource Planning, Time management, Negotiation, Cross-Functional Team Coordination, Client Communication
  • Study Therapeutic Areas:
  • Oncology, cardiovascular, Gastroenterology, medical devices, opthalmology

Certification

Medidata Rave 5.6.4 Study Builder.

Interests

Trekking, Travel blogging, vlogging, photography

Achievements and Awards

  • Received H1 Applause 'Genius' award at Dassault Systems.
  • Won Trailblazer and Wow awards at Cognizant and Tata Consultancy Services for contribution to the complex studies and delivering quality deliverables
  • Participated in the International Conference on 'Drug Discovery and Nanotechnology’ and presented poster on DNA microarray
  • Written blogs/columns in weekly magazine Sapathik Sakal and published my trekking and travel blogs
  • Participated in theatre activities in Purshottam Karandak and Sakal Karandak, state level intercollege drama competitions

Declaration

I hereby declare that the above written particulars are true to the best of my knowledge & behalf. 

Timeline

Manager, Implementation Consultant

Dassault Systems
08.2022 - Current

Principal Database Architect

Inference Clinical Research
05.2021 - 08.2022

Assistant Manager

Tata Consultancy Services
07.2013 - 05.2021

Clinical Data Programmer

Theorem Clinical Research
07.2012 - 07.2013

Programmer Analyst

Cognizant Technological Solutions India Pvt. Ltd.
06.2010 - 06.2012

Adverse Event Case Processor

Cognizant Technological Solutions India Pvt. Ltd.
12.2009 - 06.2010

Lecturer

Jayawant Institute of Pharmacy
10.2008 - 11.2009

PG Diploma - Clinical Research and Regulatory affairs

Academy For Clinical Excellence

Bachelor of Pharmacy -

Modern College of Pharmacy
Vaibhav KulkarniImplementation Consultant