Priyanka Atharva Bhalerao
Dombivali
Summary
Highly skilled in managing clinical trial data with comprehensive background in ensuring accuracy and integrity of clinical research data. Specialize in developing effective data management plans, overseeing database design, and implementing quality control measures. Strong analytical skills complement ability to lead cross-functional teams towards meeting project milestones. Positive impact on previous projects includes streamlining data collection processes and enhancing data quality, leading to more efficient trial outcomes.
Overview
9
9
years of professional experience
Work History
Sr. Clinical Data Analyst
Syneos Health
Pune
06.2022 - Current
- Experience of Complete study cycle (Set-up, conduct and closeout)
- Experience of study set up in Veeva EDC & conduct activities.
- Prepared test script and perform UAT for CDASH standard edit checks and subject scenarios
- Developed test scripts and executed UAT for PD reports and additional review reports based on protocol specifications.
- Perform external data reconciliation (RAMOS, Safety Lab, ECG, IVRS/IWRS).
- Perform serious adverse event (SAE) reconciliation.
- Work on data validation and discrepancy management.
- Coordinated with study stakeholders to facilitate clear communication and alignment on project objectives.
- Oversaw two studies in a Co-POC role, ensuring effective coordination.
- Worked on Go-live of study as co-POC.
- Successfully completed Data base lock for 1 studies as co-POC.
- Reviewed and understood protocol, guidelines & timelines.
- Issued queries within database (Inform and Veeva CDMS) for missing, inconsistent, illegible or erroneous data, follow queries to resolution and close out.
- Co-ordinate with the study manager (Client counterparts) to understand the specific requirements of study and delivered the quality work.
- Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings.
- Validation of external vendor data and escalate issues to vendor in a timely manner.
- Conducted QC of newly developed data review listings, ensuring accuracy and compliance for external vendor reconciliation and other DM reviews.
- Enhanced data reconciliation process by recommending auto checks and manual checks, improving overall data quality.
- Performed manual review of the study related parameters on regular basis during the milestones such as cohort cleaning, IDMC review, interim analysis and database lock.
- Trained peers on the new EDC system.
Data Analyst
Cognizant Technology Solutions
Airoli
03.2017 - 05.2022
- Experience of study go-live and database lock along with study conduct activities.
- Prepare test script and perform UAT for CDASH standard edit checks and subject scenarios
- Prepared test script and performed UAT for PD reports (Protocol Deviation) and other review reports.
- Perform external data reconciliation.
- Perform serious adverse event (SAE) reconciliation.
- Work on data validation and discrepancy management.
- Coordinated with study stakeholders to ensure alignment and support for study activities.
- Acted as primary liaison for three studies, ensuring effective communication among stakeholders.
- Led go-live process for study as point of contact, facilitating smooth transition to operational phase.
- Successfully completed Data base lock for 2 studies as POC.
- Reviewed and understood protocol, guidelines & timelines.
- Issued queries within database (Inform) for missing, inconsistent, illegible or erroneous data, follow queries to resolution and close out.
- Co-ordinate with the study manager (Client counterparts) to understand the specific requirements of study and conducted teleconferences with onshore clients for status updates and study progression.
- Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings.
- Validation of external vendor data and escalate issues to vendor in a timely manner.
- Performed QC of newly developed edit checks.
- Provided value additions to the study for efficient reconciliation of data by suggesting auto checks/manual checks.
- Track progress of ongoing studies, ensuring projects meet timelines and quality expectation.
- Performed manual review of the study related parameters on regular basis during the milestones such as cohort cleaning, database lock.
- Served as a primary trainer to peers on new EDC system.
- Managed large datasets effectively, ensuring accuracy and integrity of information.
Education
Master of Pharmacy -
R. C. Patel, College of Pharmacy
Shirpur, Dhule08.2016
Bachelor of Pharmacy -
MET's Institute of Pharmacy
Nashik06.2014
Skills
- Communication skills
- Independent work
- Deadline management
- Presentation skills
- Project management
- Interpersonal abilities
- Multitasking proficiency
- Enthusiasm for learning
Personal Information
- Date of Birth: 11/11/92
- Gender: Female
- Nationality: Indian
- Marital Status: Married
References
- Vaidehi Rane, Senior Clinical Data Manager, Novartis, +91-9619249693, Rane.vaidehi@rediffmail.co
- Avadhut Karle, Team Leader, Cognizant Technology Solutions, +91-9768536551, avadhut.karle@gmail.com
Hobbies and Interests
Reading
Disclaimer
12/02/2026, Dombivali, Priyanka Bhalerao
Languages
- Hindi
- English
- Marathi
Roles And Responsibilities
For Veeva CDMS
- Handled 2 studies as Co-POC, completed data base lock for 1 study, completed study set up for 1 study
- Reviewed and understood protocol, guidelines & timelines.
- Issued queries within database for missing, inconsistent, illegible or erroneous data, follow queries to resolution and close out.
- Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings.
- Validation of external vendor data and escalate issues to vendor in a timely manner.
- Performed QC of newly developed edit checks as well as vendor and DM review listings.
- Mentor new entrants in the study.
- Provided value additions to the study for efficient reconciliation of data by suggesting auto checks/manual checks.
- Track progress of ongoing studies, ensuring projects meet timelines and quality expectation.
- Performed manual review of the study related parameters on regular basis during the milestones such as IDMC cleaning, Interim analysis and database lock.
- Excelled and well versed in handling huge data.
For Inform:
- Handled 3 studies as a POC role.
- Worked on Go-live of study as POC.
- Successfully completed Data base lock for 2 studies as POC.
- Reviewed and understood protocol, guidelines & timelines.
- Issued queries within database (Inform) for missing, inconsistent, illegible or erroneous data, follow queries to resolution and close out.
- Co-ordinate with the study manager (Client counterparts) to understand the specific requirements of study and conducted teleconferences with onshore clients for status updates and study progression.
- Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings.
- Validation of external vendor data and escalate issues to vendor in a timely manner.
- Performed QC of newly developed edit checks.
- Mentor new entrants in the study.
- Provided value additions to the study for efficient reconciliation of data by suggesting auto checks/manual checks.
- Track progress of ongoing studies, ensuring projects meet timelines and quality expectation.
- Performed manual review of the study related parameters on regular basis during the milestones such as cohort cleaning, database lock.
- Served as a primary trainer to peers on new EDC system.
- Excelled and well versed in handling huge data.
Timeline
Sr. Clinical Data Analyst
Syneos Health
06.2022 - Current
Data Analyst
Cognizant Technology Solutions
03.2017 - 05.2022
Master of Pharmacy -
R. C. Patel, College of Pharmacy
Bachelor of Pharmacy -
MET's Institute of Pharmacy