Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description The Immuno-Oncology (IO) Clinical Project Coordinator is a member of the Immuno-Oncology Global Medicines (GMD) group. The IO Project Coordinator will work with a cross-functional team of experts to develop and maintain a web portal, database and robust process for the Toxicity Management Guidelines (TMGs) used across the IO Program. The individual in this role will liaise with IO project teams, the IO Lead Safety Physician, IT, external vendors, colleagues from the Site Management & Monitoring (SM&M) organization, and external investigational sites across the world. This role could be broadened in future to include other IO processes. Responsibilities: Work with IT to develop the website, associated applications and training materials that will be used by IO project teams and external investigators Maintain the database Add/remove investigator sites and maintain information on who has access to web portal Grant accesses to the portal based on IRB and Regulatory approval dates Develop communication plan and ensure it is followed Work collaboratively with key stakeholders such as IT, SM&M, and external vendors to identify a robust process for communicating changes in the database Link with the IO Lead Safety Physician and other key stakeholders to ensure proper exchange of information and a common understanding of expectations Develop and maintain the process, perform gap analyses and propose process improvements Requirements: General knowledge of the drug development process Database/process management experience in complex, multi-disciplinary environment Experience of working collaboratively in global, multi-cultural teams Proven ability to transition between roles effectively and learn rapidly in a new environment Experience of building processes and conducting gap analyses Experience in using databases and process maintenance Experience of using CTMS databases (eg IMPACT) #J-18808-Ljbffr Katalyst Healthcares & Life Sciences
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