- Merck & Co. (South San Francisco, CA)
- …writing and preparing nonclinical pharmacology regulatory document submission sections and study reports to support the development of therapeutic agents and ... Experience and Skills: Strong writing skills and experience drafting study reports, scientific manuscripts, or scientific documentsStrong computer skills, especially… more
- BeiGene (San Mateo, CA)
- …of clinical study processes + Able to independently lead large and/or complex global clinical studies + 8 or more years of progressive experience in ... timelines and budget + Leads all aspects of assigned clinical study (ies) + Leads global ...endorsement by senior management + Adheres to clinical study budgeting processes and provides input… more
- 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
- 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 Trial Physician, Rheumatology sits within Cell Therapy ... Clinical Development, which is a global organization dedicated to the effective design and execution...key Health Authority interactions and advisory board meetings as Senior Clinical Trial Physician + Authors/drafts … more
- Abbott (Pleasanton, CA)
- …hemodynamic monitoring. This position will work closely within the cross-functional clinical study team including project management, medical affairs, ... schedules while enhancing productivity and product quality. **THE OPPORTUNITY** ** Senior Manager, Clinical Science** We have an...biometrics, data management, and other clinical study personnel in addition to working… more
- Stryker (Fremont, CA)
- …more about our award-winning organization by visiting stryker.com We are seeking a ** Senior Staff Clinical Data Manager** to join our Stryker Endoscopy Division, ... to prevent future issues. **What you will do** As ** Senior Staff Clinical Data Manager,** you will...local procedures. + Train internal and external collaborators in study specific clinical data management processes, the… 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
- Ascendis Pharma (Palo Alto, CA)
- …languages), packaging, inventory, distribution, and reconciliation/returns/final destruction of IMP/CTS for global clinical studies . + Manage product ... for employees to grow and develop their skills. The Senior Manager, Clinical Trial Supplies (CTS), Oncology... study operations, ownership of distribution tracking for clinical studies , managing in documentation review and… 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
- 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
- BeiGene (San Mateo, CA)
- …to planning, label development, label & pack, and distribution for one or more clinical studies . Actively develops and oversees supply plans to ensure accurate ... provides leadership and guidance during process implementations **Essential Functions:** + Represent the Clinical Supply Chain on Clinical Study Teams (CST)… 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
- Edwards Lifesciences (San Francisco, CA)
- … Programmers in their training program development. End-users include, but not limited to, clinical study project teams, external clinical study users, ... will continue to benefit from the expertise and experience of 4,000+ dedicated global employees, a vibrant innovation engine with strong investment in our future… 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
- Pfizer (San Francisco, CA)
- …Disclosures include, but are not limited to, protocols, statistical analysis plans, clinical study reports, and clinical summaries/overviews from marketing ... ROLE SUMMARY The Clinical Trial Transparency and Disclosure Manager ( Senior...if necessary. Depending on location may need to accommodate global teleconference calls across different time zones. This is… more
- BeiGene (San Mateo, CA)
- …but not limited to, global regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory ... **General Description** + The Senior Director, Global Regulatory Lead will...and ensures timelines are met, including the review of global submission documents in support of clinical … more
