- BeiGene (Emeryville, CA)
- …Lead with writing and maintenance of the Safety Management Plans + Lead Safety Science specific investigator training **Risk Assessment, Regulatory Inquiries, ... **Essential Functions of the Job:** **Signal and Safety Data Evaluation** + Lead the identification, analysis, and evaluation of safety signals that arise from… more
- Abbott (Pleasanton, CA)
- …to: clinical trial protocols, case report forms, report of prior investigations, and investigator brochures. + Lead the process of clinical trial design, by ... job purpose and scope of the Senior Manager, Clinical Science is to lead scientific activities associated with design, conduct, and reporting of clinical trials in… more
- BeiGene (Emeryville, CA)
- …synopsis, protocol, case report and informed consent forms, clinical study reports and investigator brochure. Leads or co- lead aspects of a particular clinical ... **Quality** + Supports the development of department initiatives, including acting as lead on the development /definition of certain SOPs and processes + Ensures… more
- BeiGene (Emeryville, CA)
- …limited to, clinical study reports, clinical study protocols or amendments, investigator brochures, regulatory briefing documents, and clinical sections of INDs, ... NDAs, BLAs, MAAs and other regulatory submission documents. This person will be responsible for the management, planning and direction of a team of full-time employees and/or contractors, consisting of medical writers, document specialists, and/or QC… more
- BeiGene (Emeryville, CA)
- …across Clinical Business Operations (CBO) to optimize the value of our Investigator Payments Management portfolio. This new role, reporting to the Director of ... business capabilities that support BeiGene's Sponsor of Choice Initiative for Investigator Site Payments. Areas of focus include overseeing the Budget Development… more
- BeiGene (Emeryville, CA)
- …to key scientific/clinical discussions + Apply effective communication skills to lead and facilitate safety team meetings + Communicate relevant safety information ... development, update, and review of safety communication documents (eg, Dear Investigator Letter, Informed Consent Form, Investigator 's Brochure, Healthcare… more
- Pfizer (Oakland, CA)
- …quality of care and improving patient outcomes. + Serve as the Medical lead for assigned customers, developing and executing a medical account plan while ... populations in trials. + Appropriately provide medical support throughout the Investigator Sponsored Research (ISR) process Cultivate research and therapeutic area… more
- IQVIA (Oakland, CA)
- …as an expert in data management. May perform role of customer site lead , responsible for managing and delivering programme of studies for a customer. ... the end goal to ensure data integrations enable real time Alerts and Analytics + Lead vendor data set-up for all Data Management vendors. Work closely with the DTL… more
- BeiGene (Emeryville, CA)
- …to clinical study managers at various levels for assigned portfolio and may lead a designated therapeutic area or asset + Accountable for regional study or ... agreed timelines and budget + May act as regional lead (if needed) for one or multiple studies across...with Clinical Business Operation on optimizing efficiency related to investigator fees, site payment issues and patient travel reimbursement… more
- BeiGene (Emeryville, CA)
- …inspection readiness quality, within agreed timelines and budget + Acts as regional lead for multiple studies across an indication or across a program as required ... regional study budgets + Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities +… more
- BeiGene (Emeryville, CA)
- …working closely with Publication Manager(s). + Supports evaluation of investigator -sponsored research (ISR) applications. + Provides input and reviews development ... of scientific content for promotional activities and sales training. May be the lead medical reviewer in the review committee responsible for the review and approval… more