- Gilead Sciences, Inc. (Foster City, CA)
- …to adjust workload based upon changing priorities + Meets all requirements for Clinical Trial Manager (CTM) position with demonstrable proficiency. ... is responsible for the execution of all Phase 1-4 clinical trials , across all therapeutic areas, around...Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance… more
- BeiGene (San Mateo, CA)
- …updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal ... study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for... Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:**… more
- Gilead Sciences, Inc. (Foster City, CA)
- …out leadership vision and directions while providing expertise for Gilead's global clinical trials . Works collaboratively within the department and with cross ... Join Gilead and help create possible, together. **Job Description** ** Manager , Global Clinical Supply Chain** **KEY RESPONSIBILITIES:**...with the focus on delivering compliant, quality IMP to clinical trials globally on time in full.… more
- IQVIA (Berkeley, CA)
- …Functionally responsible for all team members throughout the duration of each clinical trial . Assures clear client communication, process documentation, and ... to manage multiple priorities within a variety of complex clinical trials * Ability to reason independently...health-related field with at least five (5) years direct clinical trial experience in a CRO or… more
- ThermoFisher Scientific (San Jose, CA)
- …a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of ... research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver... clinical research services provide end-to-end support for clinical trials from study start up to… more
- BeiGene (San Mateo, CA)
- …consistency across the organization + Provide expert knowledge on the execution of clinical trials through a deep understanding of ICH/GCP Guidelines and other ... scientific or healthcare discipline with 12+ years' experience in clinical trial industry + Both Project and...years of leadership and people management experience at managing senior manager level above persons, and experience… more
- BeiGene (San Mateo, CA)
- …with CRAs to ensure data collection is met per contractual guidelines * Works with Clinical Trial Oversight Managers (CTOMs) and Clinical Study Team (CST) to ... Familiar with industry CTMS and data management systems **Other Qualifications:** * Understands clinical trial processes with a thorough knowledge of ICH and… more
- Abbott (Alameda, CA)
- …required. + Must have 3+ years of relevant experience in site monitoring, clinical trial practices and regulations. + Experience in conducting medical device ... for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed. + Proactively...management. + Solid understanding and demonstrated experience of the clinical trial process including study design and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Manager , Biostatistics - Clinical Drug Dev - ... technical and operational statistical activities for a group of clinical trials . + Is a point of...through management of internal and external resources. + Provides senior level review of various technical documents. + Excellent… more
- Kelly Services (South San Francisco, CA)
- …+ CRO Management + Google Cloud Platform (GCP) + Good Clinical Practice (GCP) + Clinical Trials + SharePoint + Trial Management + Industry standards + ... a pivotal part in the successful execution of their clinical trials and oversight of investigative site...strong relationships with site staff and stakeholders. **KEY RESPONSIBILITIES** Clinical Trial Management: + Oversee and monitor… more
- BeiGene (San Mateo, CA)
- …performing variance analysis between budgets created at the various stages for our clinical trials . The Manager interacts interdepartmentally with Global R&D ... Pricing serves as a subject matter expert in the clinical trial site budgeting, benchmarking, and pricing...cost budget estimates and scenario modeling for BeiGene sponsored clinical trials (BEST). This position will drive… more
- Abbott (Pleasanton, CA)
- …as directed by your manager . + Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments ... to restore their health and live full lives. The ** Senior Clinical Research Scientist** is a member...as well as study sites as directed by their manager . **What You'll Work On** + Writes clinical… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Senior Manager , Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC strategies to secure ... ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present… more
- AbbVie (South San Francisco, CA)
- …submissions to health authorities (HAs), including Investigational New Drug (IND)/ Clinical Trial Applications (CTAs) IND/CTA amendments, Non-Disclosure ... to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, & others such as Commercial. Interpret FDA/European… more
- Edwards Lifesciences (Fremont, CA)
- …biostatistician of assigned clinical trial (s) in US and international/global trial + Accountable for clinical trials assigned to direct reports ... us and be part of our inspiring journey. As ** Senior Manager , Biostatistics, TMTT** , you will...the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA… more
- Abbott (Santa Clara, CA)
- …and implementation of scientific research projects. **What You'll Work On** + Writes clinical trial protocols, protocol amendments, clinical study reports, ... MN** , currently has an onsite opportunity for a ** Sr . Research Scientist** in the Abbott Vascular Division. **WHAT...bodies about submissions. + Participates in the development of clinical strategy and trial design by conducting… more
- Stryker (Fremont, CA)
- …CROs, consultants, etc. as appropriate to ensure safe, compliant and successful clinical trial conduct. + Participates in driving quality awareness in ... guidelines. + Guides Clinical employees in support of following clinical trial management processes and procedures. Allocates/re-allocates internal and… more
- Ascendis Pharma (Palo Alto, CA)
- …so, you have the chance to join Ascendis Pharma as our new Senior Manager , Statistical Programming. Ascendis Pharma is a fast-growing, dynamic biopharmaceutical ... to advance our exciting product pipeline. As our new Senior Manager , Statistical Programming, you will manage...of summary tables, data listings and graphs required for clinical trials , and CDISC datasets for regulatory… more
- Catalent Pharma Solutions (South San Francisco, CA)
- ** Senior Manager , Global Process Owner, Order...sizes to advance new medicines from early development to clinical trials and to the market. Catalent ... for Highly Potent Active Pharmaceutical Ingredients (https://www.catalent.com/oral-dose/highly-potent-active-pharmaceutical-ingredients/) . The ** Senior Manager , Global Process Owner, Order to… more
- Stanford University (Stanford, CA)
- …+ Demonstrated excellent communication skills in speaking and writing. + Multisite clinical trial management experience. + Some project management experience. + ... business development managers. You will collaborate closely with the senior research manager , CEC, to train staff...and customer service focus is required. + Experience in clinical trials operations, knowledge of clinical… more