and/or the development of clinical protocols May lead the development and/or amendments of Study Protocols, Investigator... in clinical development or as investigator for clinical trials, including experience managing clinical trial programs. Background...
(but not limited to) drafting scientific meeting briefing books, Protocols, Investigator's Brochures, annual reports, clinical and non... of clinical/regulatory document preparation, including protocols, CSRs, Investigator Brochures, and other regulatory submission...
colleagues. The US Neurology Medical Director--CNS Inflammatory Diseases will also execute activities related to investigator... and expert (KOL/HCP) outreach, investigator sponsored trials, company sponsored non-registration trials, publication planning...
of Investigator’s brochure, the clinical sections of integrated development plans (IDP), and overseeing the execution of such plans...
at the investigator meetings Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR... and safety documents and meetings: Review and/or contribute to the clinical section of the Investigator’s brochure, CTA, IND...
and regulatory documents including safety sections of protocols, investigator brochures and informed consent forms, and regulatory...
care and trainee education and should be an experienced clinical investigator and/or basic science researcher. The Director...
Negotiate investigator remuneration and prepare financial contracts Implement site close-out activities and generate site... close-out report Verify adequate investigator qualifications, training and resources, including facilities, laboratories...
(SOP) manuals; reporting of questions, discrepancies and violations to protocol investigator and study staff. Develops...