Mayuri Kapadnis
Clinical Data Manager
Kalyan
Summary
- A reliable, well-organized, and result-oriented Senior Data Manager with over 9 years of experience in core Clinical Data Management.
- Currently leading 3 studies in the conduct phase, I have extensive experience using RAVE, Inform, and Veeva Vault EDC tools.
- Expertise spans across various therapeutic areas including cardiovascular-gastrointestinal, ophthalmology, oncology, immunology, and CNS.
- Hands-on experience in study setup, conduct, migration, and closeout consistently delivers high-quality results and demonstrates reliability in carrying out study activities.
Overview
10
10
years of professional experience
7
7
years of post-secondary education
3
3
Languages
Work History
Sr. Clinical Data Specialist
Fortrea Development
04.2020 - Current
- Regular responsibilities of CDM (Data cleaning, working on queries, query resolution, Manual data review, working on erroneous data flagged through SAS checks, Database freezing, Database lock.)
- Point of contact to Monitors for data flow, discrepancy management, and all other data management related processes
- Worked on Serious adverse event (SAE) Reconciliation
- Ensure that all DM systems, documentation, validation checks, programming, access, availability and performance are in place to start the enrolment of subjects in the clinical study before the database go live
- Monitoring study status as lead Data receiver
- Allocation of study activities to Team Members and following up until completion
- Review data and take actions on discrepant data as defined in the clinical study protocol
- Ensure clinical data within e-CRF meets quality defined in data quality plan for interim review or final data release
- Support ongoing and final consistency checks through SAS listings and data listings to ensure that all data discrepancies have been handled appropriately
- Prepare manual checks based on protocol and perform data validation accordingly
- Support Third Party Data Reconciliation and SAE Reconciliation activities for the study
- Highlight all the Risks / issues to vendor and study teams for any issues identified and drive the discussions for resolution
- Lead and Monitor the progress of all data management activities for the study to ensure that study timelines are met
- Regularly follows up with sponsors, site monitors, medical coding and statistical programming team to ensure smooth functioning of a study (I.e
- Email/ Study Status meetings)
- Track progress on deliverables and production
- Proactively identifies and communicates problems/backlogs to project team & management along with proposed solutions
- Coordinate all the Data Management activities
- Monitor clinical data quality and progress of trials; drive corrective actions as needed; ensure Proper integration of third-party
- Prepare and update study documentation (KPI, Study update, Transaction tracker, Share room, sing off documents etc)
- Create and maintain Trial specific documents
Clinical Data Manager
Cognizant Technology Solutions
08.2015 - 04.2020
- Working as LDM and Data analyst on studies
- Provide high quality data as per expertise in data management that meet customer needs
- Taking Leadership and co-ordinate with Data analysts and Clients and Managers to provide comprehensive data quality
- Preparation of the Vendor transfer specification if there is any third party involved in the analysis of the clinical data
- Other Set Up activities involved User Acceptance Testing of the Screens and Edit Checks in the test database environment
- Conduct document review and provide continual feedback to study team
- Establish regular communication with Lead Data Managers, Clinical Research Associates, Clinical Trial Heads and the offshore study team members via Tele-cons and E-Mail communications
- Ensure timely and accurate dissemination of information to all team members
- Team communications/meetings are conducted on regular basis to ensure that everyone has same level of understanding
- Ensuring that the documents created are as per the protocol and any inputs provided by the On-Site/Clinical team
- Reviewed amendment requirements for documents and ensured that approved versions are in the repository
- Worked on 1 Set-up study as a primary DM eCRF creation and DVS creation
- Visit Matrix creation
- UAT testing
- Output validation
- ECRF instruction creations
- Coordination with study team external vendor
- Have worked on Mega Trail for Diabetic study
- Performed the daily review of CRFs for completeness, accuracy and consistency
- Identification of data discrepancies via computerized edit checks and manual data checks
- Review various data listings in order to identify data trends or inconsistency and highlighting them on an ongoing basis in the study team meeting or through e-mail communication
- Perform Query Management including creation, review and update of database
- Sending metrics to the Clinical team
- Monthly QC for team members, interacting with the QC team for any concerns
- Worked on Post Production Changes which involved drafting the PPC request form, writing new edit checks or modifying the existing check to make it fire appropriately
- Amending the Setup document to meet the protocol specified criteria
- During PPC working closely with different stakeholders to take approvals or amending the documents to meet the criteria
- Review of the TPD data and make sure it is as per the Clinical team requirement
- If changes required, then modify the Transfer specification and take appropriate approvals in the repository
- I have worked on lock related key deliverables, which includes sending reports on daily basis (SDV data), cleaning the subject’s data, and working closely with Clinical team in co-ordination with LDM to meet the timelines
- Action the queries/finding received from the Statisticians or Clinical
- Resolving any queries that arises from regulatory authorities pertinent to the project submitted
- Completing the Lock checklist and SDV Reconciliation activity
- After the data is clean, sending notification to respective stakeholders and locking the data on Patient-by-Patient basis
- Archiving the project reports and all project related documents
- I have worked from on site location (Poland) for AstraZeneca project for my Study
- Effectively manage time and maintain regular communication and updates to both customer and management
- Assist client's Administrators with questions and problems associated with the Study closed-out process and Documentations
Education
Bachelor in Pharmacy -
JSPM Rajarshi Shahu Collage of Pharmacy and Research
Pune, Maharashtra 01.2010 - 01.2014
H S C - undefined
Mahatma Gandhi High school
Pune, Maharashtra 01.2008 - 01.2010
S C -
Jijamata Girls High School
Satana, India 01.2007 - 01.2008
Skills
- Effective Communication Skills
- Self-Assured Decision-Making
- Time Management Skills
- Proactive Motivation
- Data Analysis and Management Skills
- Rapid Skill Acquisition
- Efficient Communication
- Effective Time Coordination
- Leadership
- Team Coordination
- Creative Problem-Solving
- Engaged Mindset
Extra-Curricular Activities
Participated in different sports events & cultural events during college Participate in poster presentation competition and national conference at MITCON institute, Balewadi, Pune
Personal Information
- Citizenship: Indian
- Date of Birth: 07/26/92
Disclaimer
I hereby declare that the information furnished by me is right to the best of my knowledge.
Timeline
Sr. Clinical Data Specialist
Fortrea Development
04.2020 - Current
Clinical Data Manager
Cognizant Technology Solutions
08.2015 - 04.2020
Bachelor in Pharmacy -
JSPM Rajarshi Shahu Collage of Pharmacy and Research
01.2010 - 01.2014
H S C - undefined
Mahatma Gandhi High school
01.2008 - 01.2010
S C -
Jijamata Girls High School
01.2007 - 01.2008
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