- 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 (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
- 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
- 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
- Danaher Corporation (Sunnyvale, CA)
- …have oversight for clinical strategy, protocol development and clinical study reports for US and OUS registration studies . + Prepare scientific content ... Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Clinical Research Scientist develops and independently… 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
- 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 (Pleasanton, CA)
- …and external customers and cross-functional teams. This FCS position works closely with Global Clinical Affairs (GCA) including the Medical Director and Program ... 114,000 colleagues serve people in more than 160 countries. ** Senior Field Clinical Specialist** **Working at Abbott**...Management, Global Clinical Organization (GCO) field personnel, and… 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
- 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
- Abbott (Santa Clara, CA)
- …regular updates to senior staff. + Creates, manages, or participates in clinical study timelines, and budgets by utilizing the appropriate project management ... Scientist Provides scientific expertise throughout the development and implementation of clinical studies . Writes/manages clinical trial protocols, protocol… more
- Abbott (Santa Clara, CA)
- …regular updates to senior staff. + Creates, manages, or participates in clinical study timelines, and budgets by utilizing the appropriate project management ... Scientist provides scientific expertise throughout the development and implementation of clinical studies . Writes/manages clinical trial protocols, protocol… more
- BeiGene (San Mateo, CA)
- …clear potential to apply their existing skills to oncology + Expert understanding of global clinical study design and drug development process from discovery ... partners. The candidate will report to the Vice President, Global Clinical Development. As a leader in...review key documents, including, but not limited to: + Clinical study reports + Abstracts, posters and… more
- Merck (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 documents + Strong computer skills,… more
- AbbVie (South San Francisco, CA)
- …key external meetings. *Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable ... site personnel, and AbbVie study staff. *Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review,… more