- Organon & Co. (Sacramento, CA)
- …execution (in collaboration with the TMED operations lead and study biostatistician), analysis and interpretation of TMED studies in accordance with the ... to 2a study protocols, in collaboration with internal (biostatistics, clinical operations ) and external (contract research organization [CRO], bioanalytical… more
- Bristol Myers Squibb (San Diego, CA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Clinical Development Lead sits within Clinical Development, ... trials. + CDLs are matrix leaders and managers who lead , develop, motivate and achieve results through teams; demonstrate...studies , with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication +… more
- Bristol Myers Squibb (Brisbane, CA)
- …teams **Key Competency Requirements** + Expertise in GCP/ICH, drug development process, study design, statistics, clinical operations + Recognized internally ... Science function which provides scientific expertise necessary to design and deliver clinical studies and programs. **Position Summary / Objective** + Partners… more
- Meta (Burlingame, CA)
- …clinical study manager to support clinical research operations . The Clinical Study Operation Lead will work closely with other clinical ... inequity in health outcomes throughout the world. **Required Skills:** Clinical Study Operation Lead...projects, regulatory studies , and a variety of clinical study designs and modes of … more
- AbbVie (Irvine, CA)
- …Clinical Development will oversee the direction, planning, execution, and interpretation of clinical studies and research activities of aesthetic clinical ... and AbbVie study staff. + Oversee global clinical study teams monitoring overall study...toxin safety and efficacy in aesthetic indications. Along with Clinical Operations , ensure overall timelines for programs.… more
- Amgen (Thousand Oaks, CA)
- … clinical strategy for the product including indications and sequencing + Partner with clinical operations to deliver the studies + Manage clinical ... well as contribute to the biostatistics analysis plan, and clinical study reports (CSRs) along with biostatistics...desirable + Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas is desirable… more
- Surrozen (South San Francisco, CA)
- …etc.) and ensure appropriate medical monitoring for clinical studies . Lead clinical study teams and update development staff and upper management ... sections of key regulatory documents, including IND annual reports and briefing packages and lead the development of clinical study documents to be used in… more
- Bristol Myers Squibb (San Diego, CA)
- … research, or equivalent + Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations + Proficient knowledge ... Science function which provides scientific expertise necessary to design and deliver clinical studies and programs. **Position Summary / Objective** +… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …**Pharmacokinetics-Pharmacodynamics (PK/PD)** and regulatory submissions. You will lead study design, execution and reporting of ** clinical pharmacology** ... development and regulatory packages **.** + Lead ** clinical pharmacology** activities related to study design,...NLME, etc. + Excellent working knowledge of phase I study design, clinical trial operations ,… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …more clinical trials + Lead project teams to design and implement clinical studies + Write protocols, investigator brochures, clinical study ... Director guides the project teams to design and implement clinical studies at high quality and in...at scientific conferences as well as clinical study investigator meetings. Where applicable, takes a lead… more
- Gilead Sciences, Inc. (Foster City, CA)
- …members of Global Supply Chain (GSC) and other Gilead functions - eg, Clinical Development, Clinical Operations , Product Development & Manufacturing (PDM), ... + Often in a matrix environment, oversees and supports clinical study planners. Facilitates issue and risk...sourcing and managing comparator drugs and other co-meds for clinical studies , and, in comparator sourcing strategy.… more
- Actalent (San Francisco, CA)
- …to and collaborate with the senior Clinical Trial Manager and VP of Clinical Operations . + Lead and participate in activities ensuring quality, ... Job Title: Clinical Trial ManagerJob Description The Clinical Trial Manager acts as a vital operations leader within the global study team, ensuring… more
- AbbVie (Irvine, CA)
- …training of investigators, study site personnel, and AbbVie study staff. + Lead global clinical study teams monitoring overall study integrity ... Description Leads the direction, planning, execution, and interpretation of clinical studies and research activities of one...toxin safety and efficacy in varied indications. Along with Clinical Operations , ensure agreed-upon study … more
- Abbott (Santa Clara, CA)
- … trials and studies in collaboration with internal stake holders including clinical project management, clinical operations , clinical science, ... specialists, project management, biostatistics, medical affairs, data management, and other clinical study personnel towards clinical evidence generation, … more
- BeOne Medicines (Emeryville, CA)
- … study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings + Leads regional operations meetings with all regional ... within agreed timelines and budget + Acts as regional lead for multiple studies across an indication...regional study budgets + Works closely with Clinical Business Operation on investigator fees, site… more
- Gilead Sciences, Inc. (Foster City, CA)
- …healthcare, consulting or academia. + Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and ... Responsible on certain projects. These activities include, but are not limited to, clinical study design and protocol preparation, additional study or… more
- BeOne Medicines (San Mateo, CA)
- … clinical pharmacology study designs and collaborate with CROs and Clinical Operations to write study protocols, amendments, and reports, ensuring ... as well. **Essential Functions of the job** **:** + Lead clinical pharmacology or pharmacometric activities on...the design and analysis of PK data from patient clinical studies . + Conduct hands-on clinical… more
- Edwards Lifesciences (Irvine, CA)
- …and be part of our inspiring journey. As the ** Clinical Operations Manager ( Clinical Imaging)** , you will lead a team of in-house clinical research ... lead the implementation of course correction. + Analyze clinical output of highly complex studies and...management and operations management experience within a clinical study setting, showcasing the ability to… more
- Abbott (Alameda, CA)
- … clinical data listings for completeness and accuracy; and escalate issues to the Clinical Operations Manager/ Study Lead as needed. + Proactively and ... monitoring and site management activities, ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH...effectively communicate the status of clinical studies to management. + Participate in… more
- Abbott (Alameda, CA)
- … clinical data listings for completeness and accuracy; and escalate issues to the Clinical Operations Manager/ Study Lead as needed. + Proactively and ... monitoring and site management activities, ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH...effectively communicate the status of clinical studies to management. + Participate in… more