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Tata Consultancy Services is an IT services, consulting and business solutions organization that delivers real results to global business, ensuring a level of certainty no other firm can match. TCS offers a consulting-led, integrated portfolio of IT, BPS,infrastructure, engineering and assurance services.
Role : Clinical Research Operations – Life Science Domain
Job Code – 106582
Location : Mumbai Area, India
Educational Qualifications : – B.Phram, Bsc. Microbiology, Bsc Biotechnology, BSc Biochemistry ,MPharm, MSC Microbology, Msc Bio technology , MSC Bio Chemistry ,MSc Chemistry
Desired Experience Level in Years : 1- 4 Years of clinical research experience.
Job Responsibilities:
- Responsible for handling Clinical Trial documents and activities as per agreed with study team.
- Supporting Sponsor Clinical Study team to meet urgent deliverables ensuring inspection readiness and Trial Master File readiness.
- Organizing Study Start-up and regular monthly teleconferences with study team, when required.
- Ensuring compliance for the Drug Shipment as per Sponsor SOP’s.
- Management and Archiving of essential documents as per Sponsor TMF SOP.
- Compilation and generation of Clinical Study Report Modular Appendices.
- Meeting process KPI.
- Participating in all appropriate meetings.
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