MedWiz Hyderabad, Telangana, India
Dec 30, 2018Full time
Job Description:Key Responsibilities: - Global Project Management for both in-house and outsourced clinical studies. - Medical and safety supervision of assigned clinical trial/project(s) from both a medical and scientific perspective - Act as medical/safety liaison between the investigators and the internal clinical operations team. - Medical oversight of trials to make sure that protocol and regulatory guidelines are followed. - Interact with investigators intermittently during study conduct to understand any recruitment and medical challenges and provide suggestions. - Preparation and Review of study documents (Protocol, ICF, CRF and CSR) to make sure that safety, regulatory and ethical compliance - Resolution of medical and safety related queries from sites and project team. - Training on handling of AEs/SAEs and safety reporting to study site team. - Initial safety assessment, as to whether AEs/SAEs meets definition of events that requires expedited reporting (SUSAR) and review/editing of narratives, - Provide assistance to the project manager to resolve the queries from the regulatories and/or the ethics committees. - Assist project team during SQVs and SIVs. - Continuous Medical Monitoring of trials which include eligibility assessment, general protocol questions, and safety and study investigational product related questions, review of lab reports, waiver requests, major protocol deviations/violations assessment and standard follow up of enrolled patients. - Presentation on protocol and study conduct, wherever required - Interaction with regulatory authorities.