Vaishali Dongare Email & Phone Number

Munich, Bavaria, Germany

Germany

Germany

Clinical Data Manager at ERT.

Mumbai Area, India

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.

M.Sc. (Bio Informatics), Bioinformatics, A

Bachelor'S Degree, Biotechnology, A