Faisal Roohi

Pharmaceuticals Clinical Development Medical Affairs

Sets strategic direction and leads clinical trials through entire life-cycle Author and/or work with others to develop publications based on the results of the clinical trials/studies in conjunction with Medical Director Develop and maintain professional relationships with academic and community-based physicians, clinicians and investigators to assure best clinical research practices

Medical Writing (preparation of protocols, synopsis, ICFs, CRFs, clinical trial agreements and providing support with clinical report writing) Line management(CRAs and project assistants) and trainings (monitoring, AE reporting, team communication, CRF writing, budget control and site relationship building) ICH GCP and Research Methodology trainings(protocol, synopsis and dissertation writing; epidemiological research methods) at institutions and hospitals nationwide

Manage the execution of project deliverables within contractual timelines and client expectations, Provide leadership, coordination, and management of the company-customer joint project team through start-up, conduct, tracking, quality, and regulatory compliance management and close-out activities among others

Spearheading the 1st investigator initiated (IIT) global H&N cancer network trial involving 20 centers and advanced hepatocellular cancer study among others. Managing regional CRAs, facilitating steering committee meetings and offering proposals and recommendations’, liaison with network investigators, site selection, newsletter preparation, responsible for study and protocol updates budgets, SIVs, SOP development and other CTM related tasks. Provide trainings in project management

Responsibilities include coordination and oversight of all clinical site management activities including management of the protocol conduct, data collection and review, and coordination of all related communication. Accountable for facilitating, tracking, and monitoring the progress of assigned site

Immunology Virology Cancers