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4 weeks ago

Mumbai, Maharashtra, India Sun Pharmaceutical Industries Full time

YOUR TASKS AND RESPONSIBILITIES Perform site feasibility identify potential investigator negotiate study budget with potential investigators finalization of investigators sites and execution of CDA and study-related contracts Preparation and submission of study documents for EC permission for respective study across centers Oversee document IP dispensing inventory management reconciliation Ensure timely site initiation site monitoring and site close-out activities are performed and respective reports are generated Investigator and site personnel training on the Study protocol procedures and GCP principles Ensure timely recruitment of trial participants and subsequent efficient and effective data entry source data verification and query resolution Ensure timely reporting of SAEs SUSARs and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies Risk identification analysis and CAPA for sites not meeting expectations as per the plan Co-ordinate with in-house or CRO partners for data management statistical analysis statistical analysis report DBL WHO YOU ARE Minimum qualification requirement is to have a Bachelor s or Masters degree in a health 1 related field such as Biology Chemistry Nursing Pharmacy or Public Health and or Post-graduate Diploma in Clinical Research Relevant experience of 1-5 years minimum in the field of Clinical Research

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