POUSHALI GANGULY
Senior CDA
Kolkata
Summary
To accept new challenges and explore new avenues of Pharmacy & Clinical Research and to secure a position that will lead to a lasting working relationship & be updated with the latest developments in the same field.
As an experienced CDM professional with expertise in Oncology, Ophthalmology, CNS and Chorionic Kidney Disease. I have successfully managed clinical trials from start-up to close out phases over the span of 9+ years. I have a proven track record of delivering high-quality work within specified timelines and have received positive feedback from clients and colleagues alike. My knowledge of clinical data management extends to UAT, test script writing, execution, and review, as well as data validation and holistic data review. Serve as primary point of contact for customer on data management deliverables and Maintain strong customer relationships. In my current role as an Sr. CDA at Syneos, I handle study conduct as a point of contact while providing comprehensive data management expertise to the team.
Overview
9
9
years of professional experience
Work History
Senior Clinical Data Associate
SYNEOS HEALTH
07.2022 - Current
- Worked on RAVE database
- Worked in Oncology Studies
- Handling Clinical Data Management activities of Study Conduct Phase and Closeout Phase
- Allocating the team members on study activities and updates
- To perform data entry, data review and query generation
- To action queries in EDC as per site response
- To prepare Query Management/Discrepancy Management Reports
- Performing UAT checks for startup and migration studies in conduct phase
- External Vendor Data Reconciliation
- IVRS Reconciliation
- Handling study related meetings and drafting and sharing the Minutes of meeting for scheduled telecalls with client
- Metrics Preparation.
Clinical Data Specialist
IQVIA
05.2020 - 07.2022
- Worked on RAVE database
- Worked in Oncology Studies
- Handling Clinical Data Management activities of Study Conduct Phase and Closeout Phase
- Allocating the team members on study activities and updates
- To perform data entry, data review and query generation
- To action queries in EDC as per site response
- To prepare Query Management/Discrepancy Management Reports
- Develop test plans for User Acceptance Testing (UAT) of checks
- Manual check output generation and query management
- External Vendor Data Reconciliation
- IVRS Reconciliation
- SAE reconciliation during study conduct
- Track study progress and issue periodic status reports
- Mentoring New Team Members and training them
- Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock
- Handling study related meetings and drafting and sharing the Minutes of meeting for scheduled telecalls with client
- Has worked on a new tool, i.e., DMLRP (Data Management Listing Review Platform).
- Participated in quality assurance reviews to verify accuracy and reliability of data.
- Minimized manual system errors with streamlined data entry process.
- Proven ability to learn quickly and adapt to new situations.
- Resolved problems, improved operations and provided exceptional service.
- Cultivated interpersonal skills by building positive relationships with others.
Junior Data Analyst
Cognizant Technology Solutions
10.2016 - 05.2020
- Worked on Inform and RAVE database
- Worked in CNS Trails, Gastrointestinal and Oncology Studies
- Handling Clinical Data Management activities of Study Conduct Phase and Closeout Phase
- Allocating the team members on study activities and updates
- To perform data entry, data review and query generation
- To action queries in EDC as per site response
- To prepare Query Management/Discrepancy Management Reports
- Develop test plans for User Acceptance Testing (UAT) of checks
- Manual check output generation and query management
- External Vendor Data Reconciliation
- IVRS Reconciliation
- SAE reconciliation during study conduct
- Track study progress and issue periodic status reports
- Actioning Global Physician Report and query accordingly
- Handling study related meetings and drafting and sharing the Minutes of meeting for scheduled telecalls with client.
Project Associate
Datacore Systems Ltd.
06.2015 - 09.2016
- Worked as an ICD coder in Insurance Coding of Emergency department
- Gained knowledge in ICD 10 with CPT coding.
- Analyzed project performance data to identify areas of improvement.
Education
B. PHARM -
West Bengal University of Technology.
Higher Secondary (12th) - undefined
WBCHSE
Madhyamik (10th) - undefined
WBBSE
Skills
Study Conduct Activities in CDM
Detail-oriented and highly organized, with the ability to prioritize and manage multiple tasks simultaneously
Well versed with MS Office (Word, PowerPoint, Excel, Access, MS Project)
Strong attention to detail and ability to identify data discrepancies and inconsistencies
Ability to work collaboratively with cross-functional teams
Experience in data cleaning, validation, and quality control procedures
Strong analytical and problem-solving skills
Experience in managing electronic data capture (EDC) systems and data transfers
Ability to generate and review data listings, tables, and figures for clinical study reports
Good Communication Skills (both in verbal and written)
Committed to responsibilities
Ability to take up Challenges
Easy reach within diverse communities
Punctual & disciplined
Team building
Self Motivation
Friendly, Positive Attitude
Accomplishments
- Winner of Ace of Rookies and Unicorn award for best work performance at Cognizant Technology Solutions.
- Winner of Bronze Awards (Twice) for Work Performance from IQVIA.
- Winner of Alpha Player Awards and EXBP formal recognition (5 times) for Work Performance from Syneos Health.
- Participated NATIONAL SEMINER (AICTE Approved) and was appreciated.
Permanent Address
14, Nivedita Sarani, Near Dr, Bagan, Kolkata-700078
Personal Information
- Date of Birth: 01/02/92
- Marital Status: Unmarried
Languages
English, Hindi, and Bengali
Extracurricular Activities
Received certificates and medals in sports, Done Junior Diploma in Painting, received medals and certificates in Drama Competitions for directing and acting.
Disclaimer
I do hereby declare that all the above-mentioned information is true and correct to the best of my knowledge and belief.
Timeline
Senior Clinical Data Associate
SYNEOS HEALTH
07.2022 - Current
Clinical Data Specialist
IQVIA
05.2020 - 07.2022
Junior Data Analyst
Cognizant Technology Solutions
10.2016 - 05.2020
Project Associate
Datacore Systems Ltd.
06.2015 - 09.2016
B. PHARM -
West Bengal University of Technology.
Higher Secondary (12th) - undefined
WBCHSE
Madhyamik (10th) - undefined
WBBSE