Job Description: - In-depth knowledge regarding clinical trial processes, the drug discovery life cycle, and computer systems used in clinical sciences. - Ability to understand life sciences and healthcare regulatory reporting and compliance. - Experience in working on documentation of system development, system testing, and the validation life cycle. - Well versed in quality control of clinical trial processes (trial startup, trial conduct, trial closeout), site documentation, and data management workflows. - Proficient in developing standard operating procedures for product development, IT processes. - Ability to independently handle all audits and inspections carried out by sponsors/regulatory agencies. - Excellent oral and written communication skills. - Experience: Min 2 - 5 years- experience Qualification: - B.Sc./M.Sc.(IT)/computer science, diploma/degree in clinical research. - Excellent verbal and written skills (English). - Good organizational, interpersonal, and team skills. - Ability to deliver results under pressure. - Goal oriented, self-motivated; able to work independently but within a team environment Desired Skills/Experience: - Identify validation requirements country/ region wise and map product functionality and compliance. - Define validation strategy, develop validation test scripts, validation protocol, validation report. - Proactive in documentation system validation process and meeting project deliverables.- Industry: Pharma/Biotech/Clinical Research- Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology (ref:biojoby.com)