Clinical Research Coordinator II, Clinical Trials-Santa Clara Kaiser PermanenteClinical Research Coordinator II, Clinical Trials-Santa ClaraSanta Clara, CASupports research compliance by: learning to draft and submit clinical trial applications, under guidance, in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures; assisting with the identification of compliance and/or quality issues, escalating as necessary; implementing updates to compliance-monitoring/audit systems and documentation with guidance; learning to and performing data entry tasks with minimal supervision to assist with risk-management; implementing research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data with minimal supervision; and leveraging basic research expertise to provide guidance to investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines. Completes work assignments by applying up-to-date knowledge in subject area to meet deadlines; follows procedures and policies, and applies data and resources to support projects or initiatives with limited guidance and/or sponsorship.
Project Manager Clinical Affairs eTeam Inc.Project Manager Clinical AffairsSunnyvale, CARemote$87–$88 / hourAs a key cross-functional partner, this role will collaborate closely with Regulatory Affairs, Quality Compliance, Program Management, Clinical Affairs, Post-Market Surveillance, Regulatory Compliance, Training, Legal, and other stakeholders to strengthen inspection readiness, support compliance execution, and enable achievement of business and clinical quality objectives. Partner with internal stakeholders to develop internal processes, KPIs and drive identified initiatives, Support the development and execution of a proactive, risk-based clinical quality and compliance program that safeguards participant safety, supports data integrity, and promotes continuous improvement across all clinical studies.
Senior Manager Clinical Affairs Intuitive Surgical IncSenior Manager Clinical AffairsSunnyvale, CAThis role will oversee and manages clinical protocols and other key study documents in support of regulatory submissions; manage clinical publications and evidence dissemination strategy, oversee manage communications with clinical trial sites, CROs, KOLs and medical societies; grow, develop and manage team to interface and support all clinical requirements of the company with the applicable guidelines and regulations; foresee challenges and develops critical concepts and methodologies to overcome those. As a key cross-functional constituent, this employee will work closely with functions across the organization - Regulatory Affairs, R&D, Program Management Office (PMO), Clinical Research Engineering (CRE), Clinical Research Managers, Global Access Value Economics (GAVE), Global Public Affairs (GPA), Regulatory Compliance, Training, Legal, and commercial functions to optimize clinical study strategies to meet business objectives.
Clinical Data Associate III Integrated Resources, IncClinical Data Associate IIIFoster City, CaliforniaFull timeEssential Duties and Job Functions: Works collaboratively with Biomarker Clinical Operations team members, Biomarker Scientists, Biomarker Statistical Programming group, Biomarker Biostatistics group, Biomarker Clinical Programming group, Biobanking and Sample Management group, and lead study clinical data associate and cross-functional study team members to meet project deliverables and timelines for biomarker data acquisition, quality checking and reporting. Knowledge, Experience and Skills: 3 years of experience and a BS degree.1 year of experience and a MS degree or PhD.Qualifications1) Lead clinical data manager with 3 -5 years of Sponsor or CRO or Academic experience2) Project management experience of clinical trials3) Understanding of clinical data management processes4) Communication with cross-functional study team members
Senior Manager/Director Clinical Operations Lycia TherapeuticsSenior Manager/Director Clinical OperationsSouth San Francisco, CARemote$169,000–$198,000 / yearAbility to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex global clinical operations issues, solicit information, listen well, persuade others, make important decisions and shape outcomes. Build, develop and train internal staff and external vendors, structure department for enhancing efficiency, and create a highly engaged work environment for attracting and retaining highly qualified clinical operations professionals.
Clinical Data Associate Integrated Resources, IncClinical Data AssociateFoster City, CaliforniaContractorEssential Duties and Job Functions:Works collaboratively with Biomarker Clinical Operations team members, Biomarker Scientists, Biomarker Statistical Programming group, Biomarker Biostatistics group, Biomarker Clinical Programming group, Bio banking and Sample Management group, and lead study clinical data associate and cross-functional study team members to meet project deliverables and timelines for biomarker data acquisition, quality checking and reporting. Clinical Data AssociateLead clinical data manager with 3 -5 years of Sponsor or CRO or Academic experienceProject management experience of clinical trialsUnderstanding of clinical data management processesCommunication with cross-functional study team membersSpecific Responsibilities:This role will immediately assume biomarker data management responsibilities for representing biomarker data management at the biomarker Sub Team (BST) meetings.
NewSenior Director, Clinical Portfolio and Program Management Allogene TherapeuticsSenior Director, Clinical Portfolio and Program ManagementSouth San Francisco, CARemote$230,000–$270,000 / yearWork with the program team members to facilitate project/program execution from Pre-IND planning through BLA/MAA approvals utilizing project management tools and processes to maintain strategic direction, project schedule/timeline, communications, budget/cost and identify and mitigate risks. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.
Senior Director, Clinical Data Management Revolution Medicines, Inc.Senior Director, Clinical Data ManagementRedwood City, CA$244,000–$305,000 / yearThe company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. The Opportunity: The Senior Director of Clinical Data Management provides high-level leadership for data management functions within clinical research, focusing on strategic development, operational execution, and regulatory compliance to ensure data integrity for clinical trials.
Clinical Flow Cytometry Account Manager – South Texas Becton Dickinson Medical DevicesClinical Flow Cytometry Account Manager – South TexasMilpitas, CaliforniaRemoteAs part of the Waters Biosciences Commercial team, drive sustainable territory growth by developing new business opportunities, expanding strategic clinical accounts, and advancing customer adoption of Waters solutions across clinical and diagnostic testing environments. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance.
Clinical Account Manager – New England (Sales) Becton Dickinson Medical DevicesClinical Account Manager – New England (Sales)Milpitas, CaliforniaRemoteAs part of the Waters Biosciences Commercial team, drive sustainable territory growth by developing new business opportunities, expanding strategic clinical accounts, and advancing customer adoption of Waters solutions across clinical and diagnostic testing environments. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance.
Payer STARS/Quality Clinical Consultant, Senior Manager PricewaterhouseCoopers LLPPayer STARS/Quality Clinical Consultant, Senior ManagerCA$124,000–$280,000 / yearAs a Payer STARS/Quality Clinical Consultant, Senior Manager, you will engage with clients in the health services sector, providing strategic guidance and operational consulting to enhance their clinical quality and performance metrics. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy .
Subject Mater Expert, Clinical Trials HCTHealthcareSubject Mater Expert, Clinical TrialsSan Jose, CAKeywords: Subject Matter Expert (SME), Clinical Trial Subject Matter Expert, Clinical Research Consultant, Clinical Research Manager, Clinical Trial Manager (CTM), Senior Clinical Trial Manager, Clinical Operations Manager, Director of Clinical Operations, Associate Director of Clinical Operations, Clinical Program Manager, Clinical Project Manager, Clinical Development Manager, Clinical Research Scientist, Clinical Scientist, Medical Affairs Manager, Research Nurse, Clinical Research Coordinator (CRC), Clinical Research Associate (CRA), Principal CRA, Clinical Trial Lead, Clinical Trials, Clinical Research, Clinical Operations, Phase I, Phase II, Phase III, Phase IV, Investigator-Initiated Trials (IIT), Multicenter Studies, Global Clinical Trials, Site Management, Trial Startup, Study Start-Up, Patient Recruitment, Site Activation, Clinical Monitoring. Experience: Minimum two (2) years of clinical nursing experience in a hospital, clinic or similar health care setting within the last three (3) years required (Bachelor’s degree may be substituted for one (1) year work experience).
Clinical Research Associate Neuralink CorpClinical Research AssociateFremont, CA$89,000–$148,000 / yearFrom navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is instrumental in translating Neuralink's BCI technology for use in people! Your work will directly contribute to the planning, execution, and success of innovative trials, from the initial phases of study setup to hands-on clinical monitoring and site management.
Clinical Trial Assistant Sagimet Biosciences IncClinical Trial AssistantFoster City, CAThe CTA will play a hands-on role in trial start-up, maintenance, and close-out activities, partnering closely with Clinical Trial Managers (CTMs),, vendors, and cross-functional internal stakeholders. The Clinical Trial Assistant (CTA) provides operational and administrative support to the Clinical Operations team in the execution of Sagimet's clinical trials.
Clinical Applications Specialist Mendaera, Inc.Clinical Applications SpecialistSan Mateo, CAYou will work closely with customers, clinical teams, product managers, and engineers to develop educational programs, train new users, support clinical deployments, and help shape the future of image-guided intervention. Qualifications Required • Registered Diagnostic Medical Sonographer (RDMS) or equivalent credential.• 5+ years of clinical ultrasound experience.• Demonstrated expertise in image acquisition, optimization, and interpretation support.•
Senior Project Manager, Clinical Affairs Intuitive Surgical IncSenior Project Manager, Clinical AffairsSunnyvale, CAAn ideal candidate brings deep familiarity with medical device development lifecycle as well as clinical lifecycle management, providing tactical guidance for execution frameworks that translate Clinical Affairs objectives into actionable plans, including development roadmaps, governance forums, prioritization, and alignment with business units and other key stakeholders. Primary Function of Position: The Senior Project Manager, Clinical Affairs, plays a pivotal role in supporting Clinical Affairs activities by partnering with key functions and business units across the organization, including R&D, Regulatory Affairs (RA), Clinical Development Engineering, Quality, and Business Unit PMOs.
Sr. Project Manager, Clinical Affairs Intuitive Surgical IncSr. Project Manager, Clinical AffairsSunnyvale, CAAn ideal candidate brings deep familiarity with medical device development lifecycle as well as clinical lifecycle management, providing tactical guidance for execution frameworks that translate Clinical Affairs objectives into actionable plans, including development roadmaps, governance forums, prioritization, and alignment with business units and other key stakeholders. Primary Function of Position: The Senior Project Manager, Clinical Affairs, plays a pivotal role in supporting Clinical Affairs activities by partnering with key functions and business units across the organization, including R&D, Regulatory Affairs (RA), Clinical Development Engineering, Quality, and Business Unit PMOs.
NewIT Project Manager (Clinical Supply Chain) IconmaIT Project Manager (Clinical Supply Chain)Foster City, CA$80.71–$85.71 / hourScope Management: Manage the approved project scope, validate business and technical requirements, monitor scope changes, assess impacts, and ensure changes are reviewed and approved through the defined governance process. Requirement and Issue Tracking: Track business requirements, functional gaps, configuration decisions, defects, issues, and action items to closure using approved project management and delivery tools.
Clinical Trial Manager Sagimet Biosciences IncClinical Trial ManagerSan Mateo, CA$90–$135 / hourAdditional responsibilities include Independent oversight of outsourced clinical studies, protocol review for operational feasibility and consistency, CRO/vendor feasibility, request for proposal and bid defense process, country/site feasibility, tracking site selection, activation, and patient recruitment. Work with junior CTM for oversight of Trial Master Files (TMF) oversight plan and laisses with CRO for annual quality check; ensuring tracking of ICH-GCP and/or FDA CRF21 essential study documents.
Vendor Manager, Clinical Operations Epicrispr Biotechnologies IncVendor Manager, Clinical OperationsSouth San Francisco, CA$135,000–$145,000 / yearManage all existing clinical vendors, requiring contract oversight and coordination with legal and internal teams, budget and PO oversight alongside internal finance and accounting, while partnering with the CTM and other Clinical Operations team members to ensure vendor deliverables align with study needs. This is a highly cross-functional role partnering closely with Clinical Operations, Finance, Legal, and external vendors to ensure studies are executed efficiently and in alignment with timelines, scope, and budget.