Oversee the plan of identifying potential investigators conducting pretrial site visits, Site Initiation, site monitoring and site close out activities, training for in house/site staff.
Oversee the site contract, Investigator agreements and study payments related to the team.
Monitoring trial drug accountability, clinical study requirements, evaluating resources.
Project management of all Clinical trials and Review Clinical Study Reporting (CSRs) as per ICH E3 Guidelines.
Oversee all studies start up activities related to clinical research like site feasibilities, site selection, study initiation and site monitoring.
Review of documents for EC submission document’s, and preparation for DCGI submission dossier and coordination for DCGI NOC
Teams coordination – Team Lead, Sr. CRA, CRA, and CRC.
Preparation & review of departmental SOP’s of the clinical department
Preparation of synopsis requested by the business development team for clinical trials and Coordinating with BD team for Feasibility questionnaires & Quotation
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