Sponsor Oversight Manager/Senior

4 weeks ago

Redwood City, California, United States Adverum Biotechnologies Full time

Adverum is looking for a SOM/ Senior SOM (Sponsor Oversite Manager). The SOM/ Sr. SOM is a critical position within the clinical team at Adverum. In close collaboration with the Clinical Trial Manager and/or Study Director, the SOM/ Sr. SOM will work to manage and provide daily operational oversight of the Contract Research Organization (CRO), study vendors, and clinical trial sites. The SOM/ Sr. SOM will partner with the Medical Monitor and other internal and external constituents to ensure clinical trial activities and deliverables are completed on time and in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and company SOPs.

What you'll do:

  • Independently manages the study start-up activities for multi-center, US, and/or global-based studies
  • May perform on-site sponsor oversite visits (feasibility, SIV, IMV, Close-out) or with CRO CRAs as needed to assess the sites' and CRA's overall performance
  • Provides monitoring oversight by reviewing monitoring schedules, metrics, and reports
  • Responsible for clinical site training and site adherence to protocol, all applicable GCP/ICH guidelines, regulations, statutes and SOPs
  • Leads or participates in vendor management activities
  • Performs in-house routine data listing review
  • Assists in managing and/or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
  • Supports CTM and/or Study Director and cross-functional representatives as required in relationship management tasks (e.g. contracts, study logistics, patient enrollments, safety, data management, etc.) to accurately coordinate clinical study activities
  • Mentors and coaches junior staff new to Clinical Research (e.g. Clinical Trial Assistant)
  • Assists with the development of protocol, informed consent development, CRFs, tracking forms, and other study-related documents
  • Performs other duties and assignments as required for the overall success of the projects. Duties my change based on the status of clinical programs and ongoing needs of the organization
  • Other responsibilities may be assigned as needed

About you:

  • Working knowledge of ICH/GCP and FDA guidelines
  • Effective verbal and written communication skills
  • Attention to detail and organizational skills
  • Ability to "roll up your sleeves" and individually contribute results to a research and development effort
  • Ophthalmology experience preferred but not required
  • Proficiency in MS Word, Excel, and PowerPoint
  • Ability to travel up to 20%
  • BS/BA, RN, or equivalent with at least 4 years of clinical trial monitoring/ clinical trial management and vendor management experience

  • Investment Banking Associate

    2 weeks ago

    Redwood City, California, United States AQ Technology Partners Full time

    AQ Technology Partners is a boutique investment bank focused on the software ecosystem, specializing in M&A and financial sponsor transactions. We are seeking an experienced Investment Banking Associate to join our team supporting transactions with growth software companies based in our Redwood City, CA office. Both investment banking and technology industry...

  • Senior Strategic Account Manager

    4 weeks ago

    Redwood City, California, United States Synthego Full time

    Do you believe that bioengineering represents the future of medical diagnostics and therapies, with CRISPR/gene editing serving as just the initial breakthrough? We are seeking an experienced, consultative sales professional to join our team, someone who finds inspiration in our mission and can contribute to our established start-up's collaborative, dynamic,...

  • Senior Strategic Account Manager

    2 months ago

    Redwood City, California, United States Synthego Full time

    Do you believe that bioengineering represents the future of medical diagnostics and therapies, with CRISPR/gene editing serving as just the initial breakthrough? We are seeking an experienced, consultative sales professional to join our team, someone who finds inspiration in our mission and can contribute to our established start-up's collaborative, dynamic,...

  • Senior Strategic Account Manager

    2 months ago

    Redwood City, California, United States Synthego Full time

    Do you believe that bioengineering represents the future of medical diagnostics and therapies, with CRISPR/gene editing serving as just the initial breakthrough? We are seeking an experienced, consultative sales professional to join our team, someone who finds inspiration in our mission and can contribute to our established start-up's collaborative, dynamic,...

  • Senior Strategic Account Manager

    4 weeks ago

    Redwood City, California, United States Synthego Full time

    Do you believe that bioengineering represents the future of medical diagnostics and therapies, with CRISPR/gene editing serving as just the initial breakthrough? We are seeking an experienced, consultative sales professional to join our team, someone who finds inspiration in our mission and can contribute to our established start-up's collaborative, dynamic,...

  • Senior Program Manager

    1 month ago

    Redwood City, California, United States Informatica Full time

    Job Number: 37053Position Title: Senior Project ManagementExternal Description:Build Your Career at InformaticaWe're looking for a diverse group of collaborators who believe data has the power to improve society. Adventurous, work-from-anywhere minds who value solving some of the world's most challenging problems. Here, employees are encouraged to push their...

  • Senior Product Marketing Manager

    2 weeks ago

    Redwood City, California, United States Bear Robotics, Inc. Full time

    Bear Robotics creates solutions for the future of automated hospitality and is a leading industry manufacturer of AI-driven autonomous robots. We are seeking a Senior Product Marketing Manager who can blend strategic thinking, creative execution, and Marketing Manager, Marketing, Manager, Product, Senior, Robotics, Technology

  • Senior Project Manager

    4 weeks ago

    Redwood City, California, United States Dexterity Full time

    At Dexterity, we believe robots can positively transform the world. Our breakthrough technology frees people to do the creative, inspiring, problem-solving jobs that humans do best by enabling robots to handle repetitive and physically difficult work.We're starting with warehouse automation, where the need for smarter, more resilient supply chains impacts...

  • Senior Project Manager

    1 month ago

    Redwood City, California, United States Dexterity Full time

    At Dexterity, we believe robots can positively transform the world. Our breakthrough technology frees people to do the creative, inspiring, problem-solving jobs that humans do best by enabling robots to handle repetitive and physically difficult work.We're starting with warehouse automation, where the need for smarter, more resilient supply chains impacts...

  • Senior Product Marketing Manager

    2 weeks ago

    Redwood City, California, United States Istituto Marangoni Full time

    Job Title:Senior Product Marketing ManagerDepartment:ProductJob Level:L5FLSA:ExemptJob Summary:Bear Robotics creates solutions for the future of automated hospitality and is a leading industry manufacturer of AI-driven autonomous robots. We are seeking a Senior Product Marketing Manager who can blend strategic thinking, creative execution, and strong...

  • Senior Technical Program Manager

    2 weeks ago

    Redwood City, California, United States Moloco Full time

    The Impact Youll Be Contributing to Moloco: Moloco is growing fast and we are looking for an experienced Senior Technical Program Manager to work across the company to drive and deliver needle-moving, state-of-the-art AdTech technology and services. You will work closely with machine learning engineers, data scientists, data analysts, software engineers,...

  • Senior Product Marketing Manager

    4 weeks ago

    Redwood City, California, United States Bear Robotics Full time

    Job Title: Senior Product Marketing ManagerDepartment: ProductJob Level: L5FLSA: ExemptJob Summary:Bear Robotics creates solutions for the future of automated hospitality and is a leading industry manufacturer of AI-driven autonomous robots. We are seeking a Senior Product Marketing Manager who can blend strategic thinking, creative execution, and strong...

  • Senior Fermentation Scientist

    4 weeks ago

    Redwood City, California, United States Codexis, Inc. Full time

    Department48 - Bioprocess DevelopmentEmployment TypeFull TimeLocationRedwood City, CAWorkplace typeOnsiteDescriptionCodexis, a biotechnology company based in Redwood City, CA, is looking to hire a Senior Fermentation Scientist. Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver technology platform to discover, develop and...

  • Senior Manager Business Development

    2 weeks ago

    Redwood City, California, United States Adverum Biotechnologies Full time

    Redwood City, CA Business Development Full Time The Senior Manager/Associate Director of Business Development will be a key contributor to the organization. This individual will provide strong business leadership in assessing and guiding the long-range strategic direction through acquisitions, joint ventures, strategic alliances, and licensing agreements....

  • Bioprocess Development Senior Fermentation Engineer

    2 weeks ago

    Redwood City, California, United States Codexis, Inc. Full time

    Department48 - Bioprocess DevelopmentEmployment TypeFull TimeLocationRedwood City, CAWorkplace typeOnsiteDescriptionCodexis, a biotechnology company based in Redwood City, CA, is looking to hire a Senior Fermentation Engineer. Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver technology platform to discover, develop and...

  • Bioprocess Development Senior Fermentation Engineer

    4 weeks ago

    Redwood City, California, United States Codexis, Inc. Full time

    Department48 - Bioprocess DevelopmentEmployment TypeFull TimeLocationRedwood City, CAWorkplace typeOnsiteDescriptionCodexis, a biotechnology company based in Redwood City, CA, is looking to hire a Senior Fermentation Engineer. Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver technology platform to discover, develop and...

  • Senior Process Engineer I

    2 weeks ago

    Redwood City, California, United States REVOLUTION Medicines Full time

    Senior Process Engineer I The Opportunity: Playing a critical role as the subject matter expert (SME) and project lead of Pharmaceutical Development within CMC function, the position will be responsible for pre-formulation studies, formulation and process development, drug delivery design, optimization, scale-up and manufacturing in support of Revolution...

  • Senior Manager, Quality Systems

    2 weeks ago

    Foster City, California, United States Gilead Sciences Full time

    Senior Manager, Quality Systems page is loaded Senior Manager, Quality Systems Apply locations United States - California - Foster City time type Full time posted on Posted 2 Days Ago job requisition id R For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job.At Gilead, we're creating a healthier world...

  • Senior Principal Product Manager

    2 weeks ago

    Redwood City, California, United States Mygwork - Lgbtq+ Professionals & Allies Full time

    This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community. Lead a team that acts as the central resource and driving force for the design, process, manufacturing, test, quality and marketing of product(s) as they move from conception to distribution. Organize interdepartmental activities ensuring...

  • Senior Employee

    3 weeks ago

    Redwood City, California, United States Stanford University Full time

    Senior Employee & Labor Relations Specialist (3 Openings)Human Resources Services, Redwood City, California, United StatesJob SummarySCHEDULEFull-timeJOB CODE4682EMPLOYEE STATUSRegularGRADELREQUISITION ID102095WORK ARRANGEMENTHybrid Eligible, On SiteStanford University is one of the world's premier academic and research institutions, devoting tremendous...