- BeiGene (San Mateo, CA)
- …updates on portfolio progress in the region to senior management and Global Clinical Study Manager as required. + Champions high-impact, ... team, provides inspirational leadership, proactive management, and feedback-oriented mentorship to clinical study managers at various levels for assigned… more
- BeiGene (San Mateo, CA)
- …regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study ... and budget + Acts as regional lead for multiple studies across an indication or across a program as...Clinical Study Report in collaboration with Global Clinical Study Manager and… more
- Pfizer (South San Francisco, CA)
- …and expectations. QUALIFICATIONS / SKILLS * Extensive clinical studies conduct, global clinical study operations, and a thorough understanding of the ... the study team delivery of multiple complex global studies and/or programs. * Responsible for...experience. Prior Experience Preferred: * Broad experience in a Clinical Study Execution discipline (eg, senior… more
- BeiGene (San Mateo, CA)
- The Associate Director (AD) Clinical Study Management leads both indirect and direct reports, external partners, consultants, vendors and external budget to ... of the study synopsis, protocol, case report and informed consent forms, clinical study reports and investigator brochure. Leads or co-lead aspects of a… more
- Abbott (Alameda, CA)
- …. This includes but not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality ... Responsible for the design, execution and monitoring of internal clinical studies . + Participate in the design,...and supplies to clinical sites and performing study device accountability. + Responsible for assisting senior… more
- Bristol Myers Squibb (Brisbane, CA)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Clinical Scientist reports through the Clinical Science function ... which provides scientific expertise necessary to design and deliver clinical studies and programs. **Position Summary /...committee (eg, DMC) activities + Drafting/review and validation of clinical study reports (CSRs) and clinical… more
- Merck (South San Francisco, CA)
- **Job Description** The ** Senior Clinical Director (Sr. Principal Scientist)** has primary responsibility for the strategic planning and directing clinical ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire...safety and efficacy as well as new drug applications, clinical study reports, or publication; and +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …manage Gilead's investigator externally sponsored research program in HIV, and serve as Gilead study lead for key interventional Phase 4 studies in HIV treatment ... affairs global lead for Gilead Sponsored and collaborative research studies + Provide high quality technical and methodological support to cross-functional teams… more
- Allogene (South San Francisco, CA)
- …product * Contribute to the design, start-up, execution, analysis and communication of the clinical studies for a product candidate * Form and enhance working ... LinkedIn. About the role: Allogene is seeking a Medical Director/ Senior Medical Director for our allogeneic CAR T cell...boards with key opinion leaders and investigators * Define clinical study protocols; recommend new clinical… more
- BeiGene (San Mateo, CA)
- …a site monitor and is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance ... with ICH-GCP guidelines, local regulations, and applicable SOPs. The SCRA collaborates with the Clinical Study Teams (CSTs) by supporting day to day clinical … more
- Actalent (Alameda, CA)
- …assist sites in efficient completion of clinical trials * Collaborates with clinical operations and other internal study team members to develop Informed ... with medical monitor. * Collaborates with team members in clinical review and interpretation of study data...a combination of academia and industry. * Participated in clinical oncology studies with molecular targeted or… more
- Abbott (Alameda, CA)
- …way people monitor their glucose levels with our new sensing technology. The Senior Clinical Data Management Analyst is responsible for performing data ... or medical or research setting is REQUIRED.** The Senior Clinical Data Management Analyst is also...**What you'll work on** * Assist in translation of clinical study requirements into trial Casebook. *… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Proven ability to successfully start-up, manage and close-out clinical studies , including authoring clinical study and regulatory documentation and ... experience managing direct reports. + Meets all requirements for Senior Clinical Trial Manager ( Senior ... studies . + Proven ability to effectively author clinical study documentation. + Functional expertise to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Proven ability to successfully start-up, manage and close-out clinical studies , including authoring clinical study and regulatory documentation and ... SOPs. + Meets all requirements for Senior Clinical Trial Manager ( Senior ... studies . + Proven ability to effectively author clinical study and regulatory documentation. + Ability… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Quality is seeking a Senior Director, Inflammation TA Lead to join our Clinical Quality Business Partners Leadership Team. In this role you will lead and set ... strategy for a global team that provides the GCP quality oversight for...+ Establish strong partnership with key business stakeholders, including Clinical Development, Clinical Operations, Regulatory Operations and… more
- BeiGene (San Mateo, CA)
- …+ Support meetings through safety data interpretation + Review of DMC/SMC materials ** Clinical Study Reports** + Provide additional summary Epi analysis to ... results to support PV activities and Safety Topic Review background **Epidemiologic Studies ** + Design protocols and conduct/contract study execution **Safety PV… more
- Abbott (Alameda, CA)
- …shipping study devices and supplies to clinical sites. + Perform study device accountability and reconciliation. + Assist senior staff in development of ... study -specific forms and trial-specific monitoring plans. + Assist senior staff in study planning, designing case...needed. + Proactively and effectively communicate the status of clinical studies to management. + Participate in… more
- Gilead Sciences, Inc. (Foster City, CA)
- … programs and studies . The Director will have experience in global clinical development and operations, innovative thinking, program/ study design ... include the design, development, and delivery of operational strategy ( global study feasibility) and other capabilities within...toward the successful design and execution of Phase I-IV global clinical trials to identify opportunities to… more
- AbbVie (South San Francisco, CA)
- …+ Responsible for having deep understanding the regulatory requirements related to the clinical studies and global drug development and accountable for ... who lead Clinical Strategy Teams (CSTs) and clinical study teams, to ensure high-quality, cross-functionally-aligned...complying with those requirements. Serves as a senior clinical representative for key regulatory discussions.… more
- BeiGene (San Mateo, CA)
- …tables, listings) **Submission Filing Safety Support** + Proactively, reviews and interprets study safety data, supports Clinical Study Report narrative ... (PAC) proposals, facilitates the design of PAC proposed safety study , executes PAC studies + Leads and...study design and filing plans. + Experienced in global regulatory requirements for pharmacovigilance + Appropriate experience with… more