Job Title: VALIDATION ENGINEER
Conduct review and design the registration of clinical studies. Monitor quality of research and responsible for Data collection and documentation. Manage the Trial Master File (TMF) ensuring all essential documents are tracked and filed in accordance with ICH/GCP guidelines. Monitor the clinical trial progress ensuring that it is recorded, conducted and reported in accordance with SOPs, protocol, GXP/ ICH and FDA 21 CFR and the relevant regulatory requirements. Responsible for site monitoring, site management, site administration and registry management for clinical studies according to GXP (GCP) and ICH Guidelines. Prepare, collect and review all essential documents throughout the study lifecycle. Provide training, administer protocol and ensure understanding of appropriate SOPs, ICH-GCP guidelines to assigned site. Responsible for preparation, completion and auditing of Informed Consent Forms. Responsible for gathering business requirement for development of Medscribe Electronic Medical Record System (EMR). Participated in drafting functional requirement and design specification for Medscribe Electronic Medical Record software. Responsible for Regression, Smoke, Functional, Blackbox and UAT testing to make sure the business requirement are fulfilled. Performed Risk Assessment and Gap Analysis for the Medscribe EMR, to ensure all regulatory FDA 21CFR, GXP, ICH and GAMP5 guidelines are met. Documentation of adverse event using MedWatch 3500a form- FDA Safety Information and Adverse Event Reporting Program. Maintain record integrity related to patient data and information in compliance with regulatory FDA, ICH and GXP Guidelines. Manage and troubleshoot problems related to documenting medical information in Amazing Charts – Electronic Medical Record software. Workflow integration between Amazing Charts – Electronic Medical Records (EMR), -Practice Management Software (PMS) and Electronic Document Management System (EDMS). Server and Software installation and management of database for the EMR, EDMS, PMS and CORI software.
Minimum Qualification Required:
Masters in Bio Technology, Bio Medical, Engineering, Pharmaceutical Sciences or Bachelors in Biotechnology, Bio Medical, Engineering, Pharmaceutical Sciences In Related Field With 5 Years Of Experience in the related field.