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Associate Director, Clinical Operations

Company: Atara Biotherapeutics, Inc.
Location: Thousand Oaks
Posted on: January 8, 2022

Job Description:

Clinical Trials Manager, Clinical Operations This Clinical Trial Manager role is responsible for the execution of a global pivotal Phase 3 clinical trial of moderate to high complexity. The CTM should proactively identify and resolve clinical project issues, manage study vendors, interact with cross-functional peers on the clinical study team. Reports to: Associate Director, Clinical Operations Location: Thousand Oaks, CA preferred (may be remote) Travel: Travel is not currently required (but could be up to 10%) Primary Responsibilities

  • Plan and attend/manage study-specific meetings (eg, study team meetings, investigator meetings); may participate in site monitoring visits such as site initiation or issue resolution visits (currently no travel anticipated).
  • Manage study timelines and metrics.
  • Responsible for managing a CRO and providing sponsor oversight of clinical monitoring activities (e.g., review of monitoring visit reports, monitoring plans, etc, to ensure completion of appropriate resolution of site-related issues including any necessary site or study level corrective action plans.
  • Facilitate cross-functional study team meetings and project manage study team deliverables.
  • Assist in managing an ongoing data review plan to enable detection of data trends and ensure study objectives are met.
  • Prepare/review study-related documents (eg, ICF template, CRFs, Laboratory Manual, Pharmacy Manual, CRF Completion Guidelines) and site study documents (eg, site-specific informed consent, study tools/worksheets, investigator contracts, site budget).
  • Manage study budget: review and approve clinical invoices against approved budget.
  • Ensure clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs.
  • Participate in the planning of quality assurance activities, coordinate resolution of audit findings, ensure audit-ready condition of clinical trial documentation (including central trial master files). Physical Requirements Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is generally performed in an office or clinical environment. Car and airplane (see above) travel is part of the job. Qualifications
    • Bachelor's degree or equivalent combination of education/experience in science or health-related field required.
    • 5+ years of clinical trial management experience within either the pharmaceuticals or biotechnology industry.
    • Strong understanding of ICH/GCP, and knowledge of regulatory requirements.
    • Strong clinical study management skills.
    • Excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team-building skills.
    • Global trial management experience is preferred but not required.
    • Strong project management skills with a focus on executing on deliverables.
    • Ability to anticipate and resolve problems effectively.
    • Possesses a sense of urgency; proactively identifies potential challenges and takes initiative to identify solutions.
    • Strong organizational skills.
    • Excellent verbal communication and writing skills.
    • Excellent interpersonal skills and the ability to communicate effectively with all internal and external collaborators. Focus on fostering and nurturing teamwork culture and philosophy. More About Atara Bio We launched -Atara Biotherapeutics -in August 2012 to help patients with serious diseases and few therapeutic options. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq -ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases. We're proud of our team of 550+ Atarians co-located by design in 4 different locations including South San Francisco (corporate headquarters), Thousand Oaks (R&D and manufacturing headquarters), Zug, Switzerland (european headquarters) and a R&D site in the Denver, Colorado area. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility.

      Our mission - "Transform the lives of patients with serious medical conditions through pioneering science, teamwork, and a commitment to excellence." Our vision - "T-Cell Immunotherapy for every patient, any time." Atara offers a competitive benefits packages that includes medical/dental/vision benefits, life and disability, retirement and stock program, as well as a generous paid time off and wellness plan that supports the well-being of our staff. Visit www.atarabio.com/careers to learn more.
      Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual's association with a member of a protected group or connection to an organization or group related to a protected group.

      We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States. Thousand Oaks, California
      Remote, Clinical Trials Manager, Clinical Operations

Keywords: Atara Biotherapeutics, Inc., Thousand Oaks , Associate Director, Clinical Operations, Executive , Thousand Oaks, California

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