Job Description: In depth knowledge regarding Clinical trial processes, 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 validation life cycle. Well versed in quality control of clinical trial processes (trial startup, trial conduct, trial close out), site documentation, data management workflows. Proficient to develop Standard Operating procedures for product development, IT processes. Ability to independently handle all audits and inspections carried by Sponsor / 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. Location: Prabhadevi (Mumbai)
Biostatistician Responsible for statistical tasks in clinical trials including design, analysis, reporting, SAPs, and meta-analyses. Provide consultation, ensure quality deliverables, support publications, and comply with GCP/regulatory guidelines.