Senior Clinical Trial Manager

1 month ago


South San Francisco, California, United States Annexon, Inc. Full time
Position Summary
The Senior Clinical Trial Manager / Associate Director, Clinical Operations (Ophthalmology) is responsible for the operational management, oversight and execution of one or more clinical trials including CROs, vendors, and consultants as needed for the conduct of clinical studies. This individual will report to the Executive Director, Clinical Operations.

Responsibilities
  • Manages one or more studies within the Annexon portfolio of clinical trials
  • Collaborates with other departments and functional groups to meet study timelines and corporate goals
  • Creates and/or oversees the design of study related documents
  • Manages study-specific CROs, vendors, and contractors
  • Reviews CRO and vendor scope of work
  • Works closely with CROs to set up study systems
  • Responsible for review and approval of IP release packages
  • Develops and tracks study budgets and financial forecasting
  • Prepares study updates and tracking information for meetings
  • Leads study management team meetings
  • Prepares and presents study-specific slide presentations
  • Attends scientific meetings as a representative of Annexon
  • Proactively identifies and communicates study-related issues
  • May participate in clinical research SOP development
  • Addresses needs of program and provides leadership
  • Attends site initiation visits as a representative of the study sponsor
Requirements
  • Experience managing clinical studies in ophthalmology drug development
  • BA / BS, RN or higher degree
  • 8+ years clinical operations experience
  • Experience with managing CTMs, CRAs and Clinical Assistants
  • Experience with early phase trials, immunology, and neurology is beneficial
  • Working knowledge of GCP/ICH guidelines
What Annexon offers
  • Diversity, Equity, Inclusion, and Belonging are important
  • Friendly workplace with flexible work schedules and remote opportunities
  • Competitive salary, equity participation, and comprehensive health benefits package
Company Summary
Annexon Biosciences is a clinical-stage biopharmaceutical company focused on bringing innovative medicines to patients with complement-mediated diseases. The company is advancing a pipeline of product candidates targeting various diseases of the body, brain, and eye. Annexon values Diversity, Equity, Inclusion, and Belonging in the workplace.

EEO Employer - Annexon highly values Diversity, Equity, Inclusion and Belonging
Annexon Biosciences is an Equal Opportunity Employer that promotes a work environment where everyone can do their best work.

Staffing Agencies
Annexon Biosciences does not accept unsolicited agency resumes. Inquiries must be sent through specific channels.

  • South San Francisco, California, United States Structure Therapeutics Full time

    Job OverviewSalary: Competitive compensation packageStructure Therapeutics is at the forefront of developing transformative therapies for patients, utilizing cutting-edge structure-based and computational drug discovery methodologies. Our innovative platform integrates state-of-the-art molecular interaction visualization, computational chemistry, and data...


  • South San Francisco, California, United States Structure Therapeutics Full time

    Job OverviewSalary: CompetitiveStructure Therapeutics is at the forefront of developing transformative therapies for patients through cutting-edge structure-based and computational drug discovery methodologies. Our innovative platform leverages state-of-the-art visualization of molecular interactions, computational chemistry, and data integration to create...


  • South San Francisco, California, United States Alumis Full time

    Position OverviewSalary: Alumis Inc. is dedicated to precision medicine, aiming to enhance the lives of individuals suffering from autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous patients with immunologic conditions still face challenges. Our mission is to significantly improve outcomes for these patients. We are...


  • South San Francisco, California, United States Meet Full time

    Position OverviewThe Senior Clinical Operations Associate will collaborate closely with the Head of Clinical Operations to facilitate the effective management and oversight of clinical trials. This role involves ensuring the integrity of trial execution and data collection while working in partnership with key study sites and investigators. The Senior...


  • San Francisco, California, United States Nurix Therapeutics Full time

    Nurix is seeking a Clinical Trial Manager (CTM)/Sr. CTM to join the Clinical Operations team. This individual will be responsible for management of global regions and/or clinical programs. They will lead study team, vendors, clinical monitors and clinical sites throughout the life cycle of a clinical trial.This individual will be able to manage clinical...


  • South San Francisco, California, United States Alumis Full time

    Position OverviewSalary: Alumis Inc. is dedicated to precision medicine, aiming to revolutionize the treatment landscape for patients suffering from autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous individuals with immunologic diseases still experience significant challenges. Our mission is to fundamentally enhance...


  • San Francisco, California, United States University of California Full time

    Position Title: Clinical Trials ManagerDepartment: UrologyEmployment Type: Full TimeJob Overview:The Clinical Trials Manager plays a pivotal role in overseeing the management of clinical research initiatives within the Urology Department. Reporting to the Clinical Research Supervisor, this position is essential for ensuring the smooth execution of various...


  • South San Francisco, California, United States Alumis Full time

    Position OverviewSalary: Alumis Inc. is a pioneering company in precision medicine, dedicated to enhancing the lives of individuals affected by autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous patients with immunologic conditions still face significant challenges. Our mission is to revolutionize outcomes for these...


  • San Mateo, California, United States Maxonic Full time

    Job OverviewPosition Title: Senior Clinical Trial Management SpecialistEmployment Type: Contractual RoleLocation: RemoteWork Arrangement: On-siteRole Summary:The Senior Clinical Trial Management Specialist plays a pivotal role in Clinical Operations, particularly within Biomarker and Bioanalytical Operations. This position demands a blend of educational...


  • San Francisco, California, United States Trial Library Full time

    About Trial Library, Inc.Our mission is to enhance health equity by broadening access to cancer precision medicine. Founded in 2022, Trial Library, Inc. is a venture-backed startup dedicated to tackling disparities in clinical trial participation. Our innovative technology, combined with human-led navigation, facilitates clinical trial discovery for...


  • San Francisco, California, United States Trial Library Full time

    About Trial Library, Inc.Our mission is to enhance health equity by broadening access to cancer precision medicine. Trial Library, Inc. is a venture-backed startup established to tackle disparities in clinical trial participation. Our innovative technology, combined with human-led navigation, facilitates clinical trial discovery for everyone, regardless of...


  • San Francisco, California, United States Trial Library Full time

    About Trial Library, Inc.Our mission is to enhance health equity by broadening access to cancer precision medicine. Founded in 2022, Trial Library, Inc. is a venture-backed startup dedicated to addressing disparities in clinical trial participation. Our innovative technology, combined with human-led navigation, facilitates clinical trial discovery for...


  • San Francisco, California, United States Trial Library Full time

    Our mission is to enhance health equity by broadening access to cancer precision medicine.Trial Library, Inc. is a venture-backed startup established to tackle disparities in clinical trial participation. Our innovative technology, combined with human-led navigation, facilitates clinical trial discovery for individuals everywhere. Our aspiration is to become...


  • San Francisco, California, United States Trial Library Full time

    Our mission is to enhance health equity by broadening access to cancer precision medicine.Trial Library, Inc. is a startup supported by venture capital, established to tackle disparities in clinical trial participation. Our innovative technology, combined with human-led navigation, facilitates clinical trial discovery for everyone, regardless of location....


  • San Mateo, California, United States Unicon Pharma Inc Full time

    Job OverviewPosition Title: Senior Clinical Trials Management AssociateDepartment: Clinical Operations - Biomarker and Bioanalytical OperationsRole Summary:The Clinical Operations team is pivotal in the global execution of all phases of clinical trials, spanning from Phase I to IV, across various therapeutic areas. This team ensures that all clinical trials...


  • San Francisco, California, United States Trial Library Full time

    Our mission is to improve health equity by expanding access to cancer precision medicine.Our vision is to be the leading discovery and recruitment platform for inclusive clinical trials.The Community Practice Clinical Data Coordinator at Trial Library will play an integral part in expanding access to cancer clinical trials by pioneering pre-screening efforts...


  • San Diego, California, United States Russell Tobin & Associates Full time

    What are we seeking in our Clinical Trial Lead? Russell Tobin & Associates is collaborating with a prominent medical device manufacturing firm to find a Clinical Trial Lead for a remote position. Employment Type: Contract/RemoteCompensation: $65-$72/hr, depending on experienceKey Responsibilities:Oversee clinical operations deliverables for client...


  • South San Francisco, California, United States Aligos Therapeutics Full time

    Job OverviewAbout Aligos Therapeutics:At Aligos, we are dedicated to transforming the lives of patients globally. As a prominent clinical-stage biopharmaceutical organization, our mission is to address critical healthcare needs.Founded in 2018 and publicly traded since 2020, we foster a science-driven culture that encompasses a wide range of expertise. Our...


  • South San Francisco, California, United States Allogene Therapeutics Full time

    Job OverviewAbout Allogene:Allogene Therapeutics, located in South San Francisco, is at the forefront of biotechnology, specializing in the innovative development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) therapies aimed at treating cancer and autoimmune disorders. Our experienced leadership team is dedicated to creating a pipeline of...


  • South San Francisco, California, United States Structure Therapeutics Full time

    Job OverviewSalary: Competitive compensation packageStructure Therapeutics is at the forefront of developing transformative therapies aimed at improving patient outcomes through innovative drug discovery methodologies. Utilizing cutting-edge computational techniques and advanced molecular visualization, we are committed to creating superior small molecule...