Direct Employer
Daily care of patients in Outpatient clinic. Some Admissions of patients Management on Ward.
Direct Employer
Serves as the Medical Monitor (MM) for clinical trials, to address patient eligibility and treatment questions in cooperation with study investigators. Review’s safety data for routine medical data review, trend review, and safety signals from ongoing trials. Reviews serious adverse event (SAE) reports from ongoing clinical studies and work in close collaboration with investigators to review causality and develop reports (including narratives and analyses of similar events) for reportable SAEs. Participates in the interpretation of data analyses of clinical trial results and developing clinical trial reports. Provides strategic and design input for clinical trials and clinical development plans. Provides input/review of clinical documents, e.g., protocols, investigator’s brochures, case report form design. Participates in site/investigator identification and evaluation for clinical trials, conducts site engagement calls, and visits. Leads preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, etc.) Serves as program medical expert for internal and external collaborators, investigators, consultants, and contract resources Represents the company at scientific meetings and presentations Contributes to scientific affairs by authoring and/or reviewing abstracts, presentations, and manuscripts for medical accuracy and content Attends and provides medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards) Develops and manage relationships with key opinion leaders for clinical programs Independently maintains the state of the art knowledge in the therapeutic area