Nilotpal Das

Dynamic Clinical Data Spec, with experience at IQVIA, excels in end-to-end CDM activities and data management. Proven ability to mentor new joiners and enhance data integrity through meticulous query management and SAS review. Passionate about driving successful study outcomes and fostering collaboration among stakeholders.

• End- to-End CDM activities including Study setup, Conduct and Close out activities.
• Study Setup: Understanding the Edit Check specifications, Data entry guidelines, Data management Plan (DMP), UAT for the assigned studies.
• Study Conduct: Experience of Data Review, Query Management, Manual and SAS listing, SAE and LABS reconciliations, Pinnacle 21. Third-party data review (ZR, DA, Source Medication listing, and labs listing etc.).
• Handling tools: LEX check, CDD check, LSH edit check, ECE edit check, CDR Dashboard checks, Jarvis, Trial manager, Endpoint and Q-test for UAT purpose.
• Worked on Database: RAVE and RAVEX.
• Data Base Lock: Worked on Data cleaning activities (Ensure all data received, manual and electronics checks completed, Lab data cleaned, all discrepancies and queries are resolved, checked the coding and SAE reconciliation is completed etc.).
• Following up with central lab for discrepant lab data management.
• Preparing Clean Patient Tracker and Manual Query Tracker, HOS (Health of study) slide.
• Analyzing Pinnacle 21 report in discrepancy data management.
• Experience of Raising DCF in Trial manager and resolving discrepant data issue of Patient reported outcome reports along with extracting all kind of e-PRO reports.
• Experience of following up with safety team, CPD team, and FM for any outstanding data issues.
• Extracting SOAR report.
• Experience of preparing.
• Experience of Query writing, query management and closing in RAVE and RAVEX to manage discrepant data.
• Giving process training and mentoring new joiners.
• Knowledge of MS excel i.e. (capturing and recording data, using shortcut and formula functions, building charts and graphs, sorting and filtering data, utilizing pivot table).
• SDO related activities: Blinded data reconciliation in Conduct and Close out phase and rave data base testing in UAT environment.
• Blinded data reconciliation as per the standard check mentioned in Secure data handling guidelines.
• Reconcile the Drug preparation and Medication kit accountability form in Rave and RaveX.
• Review of Third party blinded data, (ZR file, DA file, blinded labs file, etc.).
• Preparing Blinded SML (Source Medication listing) and Dummy SML and Reconcile the SML file as well.
• Identify and reconcile the Major Protocol Deviation (PD) and prepare the Major PD log.
• Following up with GDM and other onsite study team members to resolve the data issues.
• Representing study issues in study team meetings.
• Using Q-test tool for UAT and ADMS for other Rave related Edit check.

• Recognition received for Completing snapshot, Interim lock, final lock.
• Reward received for supporting the team as an adhoc resource and managing challenges in well planned manner to handle large volumes of data for critical study.

Date of Birth: 04/17/95

• Bike riding
• Photography
• Volleyball
• Cricket
• Football

1. Completed B.Pharm final year project on 'Treatment Protocol of Mycobacterium Avium Complex' 

2.Worked on the preparation and evaluation of mouth-dissolving tablets of Montelukast during M.Pharm

Completed industrial training from 'Bengal Chemical & Pharmaceutical LTD' at Kolkata.

I hereby declare that the above mentioned information are true to the best of my knowledge & belief.