Meghana e

About Meghana e

I\'ve spent the last 10+ years doing work that sits at the intersection of science, data…

Experience

1. Clinical Data Lead

   ThermoFisher Scientific

   Oct 2019 — Present · CA

   Responsibilities:• Developed and reviewed data management plans and data validation plans.• Assisted in developing SOPs for various data management activities.• Performed clinical trial data management activities for Phases I - Assisted in designing case report forms (CRF) and creating edit check specifications.• Responsible for developing the Test cases and Test plans and performed UAT for newstudy database.• Ensured the annotated CRF’s met the guidelines according to the protocol, checked for itsconsistency and adequacy.• Developing and maintaining of study documents including CRF completion guidelines,DMP, Data validation documents and Data Transfer Agreements.• Perform/review SAE reconciliation. Review data through listings and auto queries.• Performed freezing and locking of the data for statistical review, blinded interim qualityreview and final database lock.• Coordinated between the internal and external teams of the study and interacted withthe sites and CRA to coordinate error resolution using data clarification forms.• Reviewed frequency listings and performed QC of the data.• Ensured all the activities as per the pre-lock checklist and performed database lockactivities.• Create Study metrics to monitor study progress to ensure the expectations are met as perthe timeliness and quality.• Mentoring new joiners and providing training on organization specific Data managementworkflow.

Education

• St. Lawrence College

  Healthcare administration

• Vignan Pharmacy College, Vadlamudi Post, Chebrolu Mandalam, PIN- 522 213(CC-AB)

  B. Pharmacy

• Academy of Applied Pharmaceutical Sciences

  Clinical reasearch Drug safety and Pharmacovigilance