Prachi Abhishek Desai
Thane West
Summary
Detail-oriented Clinical Research professional with expertise in clinical data management and study support. Specializes in data validation, query management, and data integrity review while collaborating with cross-functional teams to drive successful clinical trials. Demonstrates strong analytical and problem-solving skills to navigate complex challenges.
Overview
1
1
Certification
11
11
years of professional experience
Work History
Assistant Manager
Tata Consultancy Services, Indian
09.2025 - Current
- Responsible for assigned study conduct activities in clinical trials.
- Validated clinical trial data to ensure consistency, integrity, and accuracy as per project guidelines.
- Generated and managed data queries based on validation checks and manual reviews to resolve inconsistencies.
- Coordinated with sites, monitors, clients, and internal stakeholders for issue resolution and smooth study execution.
- Performed reconciliation activities with external data sources such as IWRS and Central Laboratory systems.
- Maintained clinical data management documentation and ensured audit readiness.
- Tracked study progress and prepared Clean Patient Tracker reports for stakeholders.
- Identified study risks proactively and supported mitigation planning.
- Collaborated with cross-functional stakeholders to ensure timely project delivery.
- Contributed to process improvement initiatives and knowledge-sharing within the TCS team.
- Ensured quality deliverables in alignment with customer expectations and compliance standards.
- Performed QC activities and maintained Quality Check Plan documentation and QC logs.
- Created and maintained study dashboards to track trial health, allocation status, and completed activities.
- Managed clarification trackers and documented decisions between TCS and sponsor teams.
- Participated in study calls to discuss study status, resource planning, and issue resolution.
Senior Clinical Data Manager
Pfizer healthcare India
12.2021 - 09.2025
- Participate in activities including data review and query management, assist with quality database design including documentation testing (UAT), validation, and implementation of clinical data collection tools, CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.
- Supporting the database setup activities (risk-based monitoring, study setup, conduct, and closeout activities), data entry, and handling DB modifications/change requests (post-production changes).
- Reconciled SAE, E-diary, VRD, and PD, conducting validation checks and monitoring Cluepoint signals to ensure data integrity.
- Worked as Trial Master File (TMF) lead for multiple studies to support downstream inspection and submission readiness activities.
- Led internal training for SDQ, SAE, and VRD reconciliation to enhance team capabilities and ensure compliance with processes.
- Assisted CDS with document creation for study start-up (CCG, SDS, etc.) and collaborated with Data Managers and CDS to uphold standards, optimize data acquisition, and enhance data review and visualization.
- Attend study call with LDM and clinical team to get all issues resolved before Go-Live.
- Track and review CRF pages for PI signature and CRA verification status.
- Manage data lock and ensure timely database closure in compliance with study timelines.
Clinical data specialist
IQVIA
11.2019 - 11.2021
- Validation documentation to be updated accurately immediately upon completion of tasks.
- Minimum adherence to ALS for all assigned activities under the CPC scope.
- Work with other project support staff to identify and implement common processes. Keeps the project manager informed of any issue that may affect the smooth running of the project.
Sr. Clinical Process Associate
IQVIA
03.2017 - 11.2019
- To monitor the day to day running of designated projects.
- Study set-up phase- Up daily load detail of the participating project sites.
- Coordinate with courier points of contact to provide, courier contact, pick-up details etc. to the participating sites and process initial kit shipment for the sites.
- Conduct phase- Safety report not printed monitoring, queue monitoring, overdue sample shipment monitoring, internal pending test monitoring, monthly monitoring, and reporting to PM team, failed lab report monitoring, courier issue management and process ongoing kit shipment for the sites.
- Close out phase- Resolve all outstanding issues, send a close out memo to the sites and upload a close out checklist.
- Work with other project support staff to identify and implement common processes. Keeps the project manager informed of any issue that may affect the smooth running of the project.
- To perform mentoring activities, having an update session, and sharing the resolution.
Clinical Process Associate 2
IQVIA
06.2016 - 02.2017
- Identification, uploading, naming, categorizing of all types of documents.
- Review all documents according to batch and doing QC of own documents.
- Conduct 100% Quality check of all the documents.
- Back up lead activity i.e.query resolution and give an Allocation.
- Updating and reviewing query log daily once query is resolved by QC team, process and complete the document.
- Having update session and sharing the resolution with processor.
- Processing and Attributing Site, Country, and Core documents as per the Project Specific Requirements according to ICH-GCP.
Officer
Syntel Pvt. Ltd. Pune
06.2015 - 05.2016
- Conduct 100% quality check of all the documents, rectifying the errors before submitting the work for execution.
- Attribute mapping of documents and doing quality check of own documents before submitting to the Quality Analyst team.
- Identification, naming categorizing of all types of documents (Clinical/ Non- Clinical).
- Identified and documented duplicity in Clinical Trial documents to ensure accuracy.
- Prepared query log and shared for resolution of queries post-QC team review, processed and completed documents.
- Conducted update sessions to communicate resolution details with processors.
- Processing site contract documents with the help of Global master tracker.
Education
Post Graduate Diploma in Advanced Clinical Research -
Institute of Clinical Research India
MumbaiB.Sc. - Biochemistry
Ruia College, University of Mumbai
IndiaHSC - Science
E.S.A. College of Science
Vasai Road, MaharashtraSSC -
Utkarsha Vidyalaya
Virar, MaharashtraSkills
- Clinical Data Management (CDM)
- Project management
- Software proficiency
- Analytical Thinking
- Flexibility and Adaptability
- Self-Motivated
- Teamwork
- Honesty and Integrity
Certification
- Pursuing SAS Certified Base Programmer
- Participation at the SCDM, India (06/29/24)
Accomplishments
- Received many Appreciations in Syntel and IQVIA.
- Received many Bravo Awards in Pfizer.
Activities
- Passed Government of Maharashtra drawing Elementary exams with A grade in the year 2004
- Passed in Dr. Homi Bhabha BalVaidnyanik Competition in the year 2005
- I have given Maharashtra Talent Search Exam in the year 2006
- I have given a presentation on Production of biogas from Sewage (college)
- I have given a presentation on Marine Biotechnology (college)
- I have participated in Appetizer’s, organized by the department of Biochemistry and Food Science & Quality Control at Ramnarain Ruia College, Matunga.
- ICH GCP certified on 10/06/16
Languages
- ENGLISH
- HINDI
- MARATHI
Internship
- Pastonji ice-cream organization, Quality control & Production, 04/15/11, 05/14/11
- Shangrila Food products LTD., Quality control & Production, 03/20/12, 04/17/12
Personal Information
- Father's Name: Mr. Jagdish Maruti Tandel
- Mother's Name: Mrs. Chitra Jagdish Tandel
- Husband's Name: Mr. Abhishek Laxman Desai
- Date of Birth: 25th August 1991
- Gender: Female
- Nationality: Indian
- Marital Status: Married
Disclaimer
I certify that all the above information provided by me is true to the best of my knowledge and belief.
Timeline
Assistant Manager
Tata Consultancy Services, Indian
09.2025 - Current
Senior Clinical Data Manager
Pfizer healthcare India
12.2021 - 09.2025
Clinical data specialist
IQVIA
11.2019 - 11.2021
Sr. Clinical Process Associate
IQVIA
03.2017 - 11.2019
Clinical Process Associate 2
IQVIA
06.2016 - 02.2017
Officer
Syntel Pvt. Ltd. Pune
06.2015 - 05.2016
Post Graduate Diploma in Advanced Clinical Research -
Institute of Clinical Research India
B.Sc. - Biochemistry
Ruia College, University of Mumbai
HSC - Science
E.S.A. College of Science
SSC -
Utkarsha Vidyalaya