- Gilead Sciences, Inc. (Foster City, CA)
- … study and regulatory documentation and SOPs. + Meets all requirements for Senior Clinical Trial Manager (Senior CTM) grade 28 position with demonstrable ... is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key… more
- Vera Therapeutics (Brisbane, CA)
- Title: Clinical Trial Manager Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing ... medical treatment for patients suffering from immunological diseases. Position Summary: The Clinical Trial Manager will report to the Senior Director, … more
- Pfizer (San Francisco, CA)
- ROLE SUMMARY The Clinical Trial Transparency and Disclosure Manager (Senior Manager ) is an integral member of the Medical Writing department. The role is ... responsible for preparing clinical regulatory documents pertaining to Pfizer-sponsored interventional ...but are not limited to, EMA Policy 0070, EU Clinical Trial Regulation, Health Canada Public Release… more
- Vera Therapeutics (Brisbane, CA)
- Title: Clinical Trial Manager Associate Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on ... treatment for patients suffering from immunological diseases. Position Summary: The Clinical Trial Manager Associate will report to the Senior Director,… more
- Stryker (Fremont, CA)
- …The role will lead the establishment and management of databases for clinical trials . This involves ensuring that all data-related operational aspects ... + Develop complex status reports, specifications for analysis of clinical trial data for interim and final...clinical data management, preferably medical device or pharmaceutical clinical trials required + Knowledge with imaging… more
- Abbott (Pleasanton, CA)
- …conduct of clinical trials , including but not limited to: clinical trial protocols, case report forms, report of prior investigations, and investigator ... scientific activities associated with design, conduct, and reporting of clinical trials in the therapeutic area of...brochures. + Lead the process of clinical trial design, by collaborating closely with… more
- Bristol Myers Squibb (Brisbane, CA)
- …and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials + Successfully leads, plans, and executes ... May support clinical development planning (collaboration with Clinical Development Lead/ Clinical Trial Physician...unique perspectives in an inclusive culture, promoting diversity in clinical trials , while our shared values of… more
- BeiGene (Emeryville, CA)
- …+ Create supply and inventory plans and develop production schedules for clinical trial materials. + Monitor schedule adherence of production schedules ... **General Description:** The Sr Manager of Clinical Supply Chain manages...business process development **Competencies:** + Demonstrates knowledge of global clinical trials and the drug development process.… more
- BeiGene (Emeryville, CA)
- …quality study timelines and tracks progress towards these + Ensures that the clinical studies are operationally feasible, oversees trial feasibility, trial ... timelines and budget + Leads all aspects of assigned clinical study(ies) + Leads global cross-functional study team (including...Ensures study plans (eg project management plan, monitoring plan, Trial Master File plan, data monitoring plan, ) are… more
- BeiGene (Emeryville, CA)
- …regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at ... 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
- AbbVie (San Francisco, CA)
- …development of data and reporting standards in support of AbbVie's portfolio of clinical trials and ensuring AbbVie's conformance to CDISC standards and industry ... Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager , Clinical Data and Reporting Standards (CDARS)...to CDISC. + Review and provide feedback on SDTM Trial Design Domains + Oversee the creation of SDTM… more
- Abbott (Alameda, CA)
- …of clinical trial data throughout the full lifecycle of multiple clinical trials according to the Code of Federal Regulations, ICH GCP, and ISO14155. ... Assist senior staff in development of study-specific forms and trial -specific monitoring plans. + Assist senior staff in study...for completeness and accuracy; and escalate issues to the Clinical Operations Manager /Study Lead as needed. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …regulatory, scientific, and business objectives. **Key Skills** + Has excellent understanding of clinical trial data flow and clinical programming process. + ... skills, as well as strong interpersonal abilities. + Has a deep understanding of clinical trial design, data curation, and validation processes. + Adept at… more
- Abbott (Alameda, CA)
- …processes. This role is critical to the successful collection, reporting and analysis of clinical trial data as well as the mentorship of junior team members. ... **What you'll work on** * Assist in translation of clinical study requirements into trial Casebook. *...field. + Expert in data collection best practices for clinical trials . + Expert knowledge of global… more
- BeiGene (Emeryville, 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
- BeiGene (Emeryville, CA)
- …to ensure different perspectives, ideas and expertise are reflected when executing clinical trials + Develops, refines, and articulates regional goals, inspiring ... and SOPs as required. + Drives deliverables regionally for trial or portfolio **Essential Functions of the job:** **Regional...progress in the region to senior management and Global Clinical Study Manager as required. + Champions… more
- Avispa Technology (South San Francisco, CA)
- …the support of clinical systems that are used in the development of the clinical trials in ECD (Early Clinical Development). The ideal candidate has 7+ ... and maintenance of interactive response technology solutions to support clinical trials . * Provide technical oversight to...Good Clinical Practices and FDA regulations governing clinical trial execution. * Detail-oriented and able… 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
- Abbott (Alameda, CA)
- …+ Must have 3+ years of relevant experience in site monitoring, clinical trial practices and regulations. **Preferred Qualifications** + Demonstrated excellence ... 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
- Vera Therapeutics (Brisbane, CA)
- …(s). Responsibilities: * Supports clinical operational components of global clinical trial management and vendor management during start-up, conduct and ... Title: Clinical Project Associate Location: Brisbane, CA About Us:...and staffing companies) are prohibited from contacting our hiring manager (s), executive team members, or employees. We require that… more