Experience

Trium Analysis Online GmbH

• Germany
• IT Services and IT Consulting
• 1 - 100 Employee

• Project Manager

  • Nov 2019 - Present



ERT

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Data Manager

  • Nov 2018 - Oct 2019

  Clinical Data Manager at ERT. Clinical Data Manager at ERT.



Tata Consultancy Services

• India
• IT Services and IT Consulting
• 700 & Above Employee

• Clinical Data Manager

  • May 2013 - Apr 2018

  Worked as a Clinical Data Manager for different therapeutic areas like Cardiovascular, Respiratory, NeuroScience and Anemia.- Worked on Electronic data capturing system InForm (v4.6 and v6.0).- Worked on Lab, PK, PGx, ECG, PFT, Diaries and SAE reconciliation.- Expertise in Query Management, Discrepancy Management, Holistic Data Review- Worked on Client specific tools (EXACT, SPECTRE, Study Explorer, EDU).Key work Points:- Worked on startup activities such as Test script review, drafting eCRF completion guideline, Pre UAT testing, Screen review, writing specification for SAS checks.- Execute Data Management activities viz. Data Cleaning, working on Manual and System Checks, Updating relevant trackers, Query Management, Discrepancy Management, Data Review.- Performed study closeout activities like Locking & Freezing of forms/visits & casebooks.- Prepared Study Metrics Reports, Clean Patient Trackers, Study Progress Report as per client specifications.- Performed Local Lab reconciliation by using the Client local lab database- Communicate with Customers, monitors, coders, external vendors as required for issue resolution.- Worked on archiving activity (Review TMF checklist).- Running various client specific tools to process all external data, performing data loads, deliverables via External Alliance Portal(EAP), Putty, External Data Utility(EDU), EXACT, SPECTRE to perform data reconciliation process.