Experience

Max Neeman International

• India
• Biotechnology
• 100 - 200 Employee

• Validation Associate

  • Jul 2013 - Present

  Brief summary of relevant clinical research experience:In Production:• Data Validation Plan preparation.• Validation Check implementation and testing.• Database designing like “PheedIT” (SAS based).• Updating the DMSF (Study files).• Validation and Query generation for discrepancies.• Preparing and maintaining “Track records/Excel Trackers” for all the activities/ proceedings in a study such as tracking of the number of CRFs validated, Number of resolutions pending from site, Number of Queries resolved etc.• Protocol trainings.• Providing study status on timely basisIn Development:• Prepare and update Annotation List, data Validation Plan, Edit Check Specification, and Database/ Data entry Screens as per study requirements• Perform query management activities per study requirements including the manual queries raised by data entry team and medical coder; i.e. query generation and resolution• Filling the data in 2 CRFs for data base testing.• Validate the external data after uploading into the database.• Update Self Evident Correction queries in Self Evident Correction Form per study• Update reports and trackers on regular basis or as per study requirements. Clinical Trial Phase Endocrinology – Type-II Diabetes Phase III; Oncology- Breast Cancer Phase II; Cardiology-Heart Failure study Phase II; Psychological (Alcohol dependence) Phase III; Device Study Phase II Chronic Kidney Diseases(CKD) Show less

• Process Associate

  • Jun 2012 - Jun 2013

  • Query Check testing• To enter the Laboratory data in the database.• To perform database screen testing database.• Providing study status on timely basis.• Preparing and maintaining “Track records/Excel Trackers “for all the activities/proceedings in a study such as tracking of the number of CRFs entered, Number of queries resolved etc.