Clinical Trial Associate - 1 Opening(s) - "D"

Sun Pharmaceuticals Industries Ltd (SPIL) is one of the leading players in the Indian Pharmaceutical industry with global operations.What we offer to an individual is an opportunity with one of the most dynamic organizations in the pharmaceuticals industry, a steep learning curve, career path, individual responsibility and a healthy working atmosphere.

Designation	Clinical Trial Associate - 1 Opening(s)
Job Description	Prepare documents for clinical dossiers for DCGI and USFDA submission Prepare dossiers for Ethics Committee (EC) submission Assist project manager in site selection process and document collection Prepare Confidentiality Disclosure Agreement (CDA), feasibility questionnaires and clinical study agreements with investigators in collaboration with the project manager Prepare for Investigator meeting and document minutes and project meetings Send Stationery Start-up kit to sites and site master file along with applicable logs and documents Ensure regular status reports, clinical study report (post close out) to EC by sites Arrange trial document archival at sites, in-house, and/or by third party as applicable Check the trial master files regularly and document the deficiencies and get them resolved in liaison with site/ CRA Accountable for the trial master files for the projects handled Coordinate for translations, back translations and calibration of equipment at site and maintain central inventory of instruments Close in-house trial file after all activities required for the same Coordination for audits : Face in house audit and close all audit observations, coordinate with sites for closing site audit findings related to documentation
Desired Profile	Please refer to the Job description above
Experience	1 - 6 Years
Industry Type	Pharma / Biotech / Clinical Research
Role	Clinical Research Associate/Scientist
Functional Area	Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Education	UG - B.Sc - Any Specialization, B.Pharma - Pharmacy  PG - M.Sc - Any Specialization  DOCTORATE - Any Doctorate - Any Specialization, Doctorate Not Required
Location	Mumbai
Keywords	Clinical Research, clinical Dossiers, Clinical Trails, clinical data management
Contact	Sun Pharmaceutical Industires Ltd  Acme Plaza, Andheri-Kurla Road, Andheri(East).  MUMBAI,Maharashtra,India 400059
Job Posted	07 Oct

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