Current jobs related to Senior Clinical Study/Project Manager - Sunnyvale - Intuitive

  • Senior Clinical Study/Project Manager

    3 months ago

    Sunnyvale, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of the PositionThis position requires a candidate with extensive experience helping evidence generation strategy and execution of clinical studies. The Clinical Study Manager-4 (CSM IV) role will develop and execute strategies for clinical and outcomes research studies to help regulatory approvals and key strategic evidence...

  • Senior Clinical Trial Manager

    2 weeks ago

    Sunnyvale, California, United States I.T. Solutions, Inc. Full time

    Job Title: Senior Clinical Trial ManagerOur company, I.T. Solutions, Inc., is a leading provider of genomic medicine solutions. We are seeking a highly skilled Senior Clinical Trial Manager to join our team.Job Summary:The Senior Clinical Trial Manager will be responsible for the day-to-day operations of assigned clinical trials, including start-up, conduct,...

  • Senior Clinical Trial Manager

    3 weeks ago

    Sunnyvale, California, United States I.T. Solutions, Inc. Full time

    Job Title: Senior Clinical Trial ManagerWe are seeking a highly skilled Senior Clinical Trial Manager to join our team at I.T. Solutions, Inc. This is a unique opportunity to work with a genomic medicine company focused on treating debilitating neurological diseases.Job Summary:The Senior Clinical Trial Manager will be responsible for the day-to-day...

  • Sr. Clinical Study Manager

    1 month ago

    Sunnyvale, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of the PositionThis position requires a candidate with extensive experience helping evidence generation strategy and execution of clinical studies. The Clinical Study Manager-4 (CSM IV) role will develop and execute strategies for clinical and outcomes research studies to help regulatory approvals and key strategic evidence...

  • Senior Clinical Trial Manager

    2 days ago

    Sunnyvale, United States I.T. Solutions, Inc. Full time

    Our Client is a genomic medicine company focused on treating debilitating neurological diseases, by using our wholly owned, highly versatile zinc finger epigenetic regulation technology and capsid delivery engine. We are passionate about designing and developing genomic medicines to transform the lives of patients suffering from severe diseases with our deep...

  • Senior IT Project Manager

    1 week ago

    Sunnyvale, California, United States Info Way Solutions Full time

    Job Summary:Info Way Solutions is seeking a highly skilled Senior IT Project Manager to lead our team in delivering successful projects. The ideal candidate will have a strong background in Agile project management, with experience in Java and .Net technologies.Key Responsibilities: Accomplish project results by communicating job expectations, managing and...

  • Senior Project Manager

    2 weeks ago

    Sunnyvale, California, United States ClinDCast LLC Full time

    Job OverviewClinDCast LLC is seeking a highly experienced Senior Project Manager to lead our IT programs and projects. The ideal candidate will have a strong background in project management, team building, and knowledge transfer.Key ResponsibilitiesManage IT programs and projects from initiation to closureBuild and lead high-performing project teamsDevelop...

  • Senior Project Manager

    1 month ago

    Sunnyvale, California, United States ClinDCast LLC Full time

    Job DescriptionClinDCast LLC is seeking a highly experienced Senior Project Manager to lead our IT programs and projects. The ideal candidate will have a strong background in project management, team building, and knowledge transfer.Mandatory Skills:At least 7 years of experience providing technical and management services to government agencies.Proven track...

  • Senior Oracle Project Manager

    4 weeks ago

    Sunnyvale, California, United States Talent Groups Full time

    Job Title: Senior Oracle Project ManagerJob Summary:We are seeking a highly experienced Senior Oracle Project Manager to lead our Oracle EBS projects. The ideal candidate will have a strong background in IT project management, with a focus on Oracle implementations.Key Responsibilities:Lead IT projects from initiation to delivery, ensuring timely and...

  • Senior IT Infrastructure Project Manager

    2 weeks ago

    Sunnyvale, California, United States GForce Life Sciences Full time

    Job Title: Senior IT Infrastructure Project ManagerJob Summary:We are seeking a highly skilled Senior IT Infrastructure Project Manager to join our team at GForce Life Sciences. The successful candidate will be responsible for planning and coordinating all aspects of internal information system-specific projects from initiation to delivery.Key...

  • Clinical Data Manager III

    2 weeks ago

    Sunnyvale, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of the PositionThe candidate will manage design, develop, implement, validate, maintain, and support clinical databases related pre-market or post- market clinical studies/registries. The candidate will have an understanding of data design, development, implementation processes to develop EDC systems. The candidate will be...

  • Senior Clinical Engineer

    3 weeks ago

    Sunnyvale, California, United States Noah Medical Full time

    About the RoleNoah Medical is seeking a highly skilled Senior Clinical Engineer to join our team. As a key member of our development team, you will be responsible for representing clinical value propositions for patients and providers throughout the design and development of new products.Key ResponsibilitiesDevelop internal expertise in clinical domains...

  • Senior Clinical Engineer

    3 weeks ago

    Sunnyvale, California, United States Noah Medical Full time

    About the RoleWe are seeking a highly skilled Senior Clinical Engineer to join our team at Noah Medical. As a key member of our development team, you will play a critical role in representing clinical value propositions for patients and providers throughout the design and development of new products.ResponsibilitiesDevelop internal expertise in clinical...

  • Senior Technical Project Manager

    2 weeks ago

    Sunnyvale, California, United States Info Way Solutions Full time

    Job Title: Senior Technical Project ManagerWe are seeking a highly experienced Technical Project Manager to lead our Java and microservices projects. The ideal candidate will have a strong background in project management, Java development, and microservices architecture.Key Responsibilities:* Lead and manage multiple technical projects simultaneously*...

  • Senior Clinical Engineer

    2 weeks ago

    Sunnyvale, California, United States Noah Medical Full time

    About the RoleNoah Medical is seeking a highly skilled Senior Clinical Engineer to join our team. As a key member of our development team, you will be responsible for representing clinical value propositions for patients and providers throughout the design and development of new products.Key ResponsibilitiesDevelop internal expertise in clinical domains...

  • Senior Electrical Project Manager

    1 week ago

    Sunnyvale, California, United States EMCOR Group Full time

    Job SummaryThe Senior Electrical Project Manager will lead all aspects of electrical project activities for assigned projects in accordance with project goals, budget, quality control, and company objectives. This role is responsible for providing project management resources to act for the company in matters pertaining to the successful progress and...

  • Senior Information Technology Project Manager

    7 hours ago

    Sunnyvale, United States GForce Life Sciences Full time

    Senior IT Project Manager – Sunnyvale, CA Must be able to work on a W2Job Summary: Our client is seeking a motivated Senior Project Manager to provide program management and leadership for multi-functional product development teams in the Business Applications and Operations Portfolio. As a Senior Project Manager, you will develop a complete plan of record...

  • Sr. Clinical Research Associate

    1 month ago

    Sunnyvale, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of the PositionThe Senior Clinical Research Associate will play a key role in proactively helping the conduct of pre-market and post-market clinical studies to ensure compliance with all the regulatory requirements.  The ideal candidate will have a thorough knowledge of Clinical investigation of medical devices for human...

  • Project Management Manager

    3 weeks ago

    Sunnyvale, California, United States Northrop Grumman Full time

    Job Summary:We are seeking a highly motivated and detail-oriented Manager Project Management to lead and manage all aspects of office and administrative operations. The Manager of Project Management will serve as the primary liaison between external and internal customers, ensuring the seamless integration of the Launcher Operating Unit (OU) with other...

  • Senior IT Project Manager

    1 week ago

    Sunnyvale, California, United States Futran Tech Solutions Pvt. Ltd. Full time

    Job Title - Technical Project ManagerLocationEmployment TypeJob DescriptionAs a Technical Project Manager at Futran Tech Solutions Pvt. Ltd., you will oversee the entire project, ensuring timely completion and meeting client expectations. Your expertise in IT project management, combined with your technical knowledge, will drive project success. Key...

Senior Clinical Study/Project Manager

2 months ago

Sunnyvale, United States Intuitive Full time
Job Description

Primary Function of the Position

This position requires a candidate with extensive experience helping evidence generation strategy and execution of clinical studies. The Clinical Study Manager–4 (CSM IV) role will develop and execute strategies for clinical and outcomes research studies to help regulatory approvals and key strategic evidence initiatives. As a member of the Clinical Affairs team, this role will be responsible for working with key stakeholders to design and develop clinical protocols and execute clinical studies (pre–market or post–market studies), with minimal supervision. The candidate will be required to work closely with clinical research associates (CRAs), clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, develop clinical study reports, or help the development of clinical publications. During trial execution, the CSM will drive the progress of the trial during site selection, site start–up and through enrollment and follow–up. The CSM will clearly provide guidance to the monitors about monitoring needs, and oversee compliance work on the study. The CSM will also take a leadership role in external communication with investigators and study teams. The ideal candidate will have experience previously managing premarket studies in the United States and utilizing resources to research and scope research topics and to provide recommendations on clinical trial strategy. The candidate is also expected to have experience reviewing, interpreting and summarizing clinical literature.

Essential Job Duties

Responsible for leading assigned clinical research activitiesPartner with internal stakeholders, investigators and KOLs to develop and review study design and concepts, prepare protocol and study outlines and subsequently driving identified initiativesResponsible for the planning and execution of the clinical studies including site selection, review of potential patient recruitment and projections, creation of study related documents (protocols, case report forms, Informed consents, Clinical trial agreements, study reports), organizing IRB/EC submissions with follow–through to ensure successful progressResponsible for autonomously conducting clinical studies on schedule and within budget while ensuring high quality and compliancePerform on–site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits.Conduct clinical study monitoring to ensure regulatory and protocol compliance as well as overall data accuracy in accordance with the study clinical monitoring planComplete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a case report form at sites or in data listings to ensure regulatory and protocol compliance and overall accuracyLiaise with sites and help in internal audit/inspection and ensure sponsor audit readinessLiaise with external vendors and sites to negotiate contracts and budgets in collaboration with the legal team and managementTrack study progress and provide regular status reportsWork closely with Biostatisticians on data analysis, interpretation and synthesis, in order to develop clinical study reports and/or help development of scientific publicationsTrack, process and manage site payments and help in study financial tracking by developing tracking tools as necessaryOrganize and drive study meetings and other study activities as assignedMentor junior clinical study manager(s); provide guidance to CRAs and CTAs on monitoring and other study needsFollow corporate (e.g., SOPs) and regulatory requirements (e.g., GCP and US and OUS guidelines) and proactively manage studies, following such guidelines and requirementsConduct literature searches and familiarize with literature to stay informed and abreast of relevant scientific/clinical knowledge and/or to establish evidence gapsCritically appraise scientific literature and write clinical summaries to assist research and the development of clinical strategies and clinical investigational protocolsReview and revise Clinical Operations Standard Operating Procedures (SOPs) to assist Clinical Affairs leadership with continuous process improvement initiativesFor post–market research, collaborate with commercial groups (i.e., marketing) to know about market trends and utilize information to support of business goals through Clinical Affairs activitiesFor post–market research, provide scientific expertise to the Health Economics and Outcomes Research department for development of outcomes research analysis (including identification of appropriate diagnosis or reimbursement codes, selection of clinical outcomes for procedures of interest)Work with clinical investigators to prepare manuscripts, abstracts, slide presentations, and poster presentations for scientific meetings and publications in collaboration with managementHelp regulatory submission and approval of pre–market clinical studies and 510k(s), responsible for addressing regulatory body questions on clinical study design and results (e.g., protocol, ICF, eCRF, clinical study reports).