8.0 - 13.0 years

8 - 18 Lacs

ahmedabad

Work from Office

Role & responsibilities Conduct external site audit (Late Phase) to ensure compliance with SOPs, Protocol, ICH GCP, and applicable regulatory requirements. Review of study documents like study protocol, inform consent, eCRF, Data management plan, study plans, Statistical analysis plan (SAP), clinical study report, etc. Audit study database in various clinical data management systems. Review and maintain QMS documents like change control, protocol deviation, etc. Review study TLFs (Table, listing and figure) Review validation documents of software used in clinical studies like clinical data management system (CDMS), eTMF, Clinical trial management system (CTMS), etc. Responsible for planning, conducting and reporting of system audit of clinical trial, clinical data management, software development and Bio-stat departments. Responsible for planning, conducting, and reporting of vendor audits. Review SOPs of various departments like clinical trial, clinical data management, software development, Bio-stat, etc. Preferred candidate profile Minimum 8 years of experience Candidate must have experience in the Clinical Trials field QA experience preferred

Posted 6 days ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.