Major purpose of the Job: To conduct Audit for BE Clinical, Clinical Trial, Medical Writing, Clinical Data Management, IT, Archival Department to ensure that activities are conduct as per applicable SOP and Regulatory Requirements. Responsibilities: Maintaining Document control in CRO -Issuing controlled/ documents, and other approved uncontrolled/usage copies of SOPs, forms/formats/logbooks, study documents of CRO. -To check that correct documents are issued before issuing the same. -To update and maintain the master document file. -Issuing and compiling deviation forms and maintaining log. -Issuing and compiling change control forms and maintaining log. Review of documents for BA-BE/CT department of CRO -Online Audit for each phase of BA/BE studies. -Clinical Trial site audit for ensuring trial related activities are conducted as per Protocol and Approved Documents. -Retrospective data review of BE Clinical and CT Department. -Maintaining Document Control in CRO. -To conduct system audit in BE Clinical and Clinical Research Department. -Review of validation/ calibration & maintenance of equipment's and software. -Handling of sponsor audit, queries resolution and response of sponsor queries & audit report. -Ensuring updation of CRO procedure and SOPs according to current regulatory, guidelines. -To conduct vendor qualification. -Reviewing of SOPs, protocols, study plan and draft reports of respective department of CRO. -Review of system audit trial for all instrument/ equipment's/ software of CRO. Compliance: -Ensuring BA/BE and CT studies are conducted in compliance with applicable regulations, guidelines, and Standard Operating Procedures (SOPs). -Interpreting and applying regulatory requirements to BA/BE and CT activities. -Maintaining current knowledge of relevant regulations and guidelines. Data Integrity: -Monitoring compliance with data integrity principles (e.g., ALCOA++). Communication and Collaboration: -Communicating effectively with CRO staff, study directors/PIs, and other stakeholders on qualityrelated issues. -Collaborating with other departments (e.g., laboratory operations, data management, clinical operations).
