Acts as medical/clinical lead for assigned development programs.
Leads the development of protocols, IB, CDP, TPP, annual IND reports, severe adverse advent reports, periodic safety update reports, clinical study reports, and clinical/scientific strategy across phases 1-3 for assigned programs.
Interacts with CROs to plan, execute, and monitor clinical trials; recruits/selects competent investigators in collaboration with Clinical Operations; ensures adherence to Good Clinical Practices (GCPs); monitors data for safety and efficacy trends; and collaborates on writing clinical reports.
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.