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Manager, GMA Clinical Trial Management & Resources

Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: June 22, 2022

Job Description:

Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThe Manager Clinical Trial Management & Resources provides support for all aspects of Global Clinical Operations with high degree of quality in the execution of all Global Oncology Medical Affairs (GOMA) External Sponsored Research (ESR) or Expanded Access Program (EAP) study activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. Facilitate successful execution, and adherence to timelines and clinical milestones of GOMA clinical activities as appropriate.Responsibilities

  • Clinical Operations Study/ Program ManagementExternal Sponsored Research (ESR) or Expanded Access Program (EAP)
    • Support the preparation, set-up, and execution and reporting of all clinical trial activities, ensuring adherence to timelines, budgets, project, and quality plans, and relevant ICH/GCP Guidelines Review protocols to ensure designs are implementable to efficiently achieve the objectives.
    • Support activities to drive adherence to timelines, program objectives and monitoring plans.
    • Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems.
    • External Sponsored Research (ESR): Investigator Initiated Studies (IIS) and Collaborative Externally Sponsored Research (CESR), or Expanded Access Program (EAP)
    • Support the oversight of the overall IIS and CESR or Expanded Access Program (EAP) process per the Standard Operating Procedure (SOP) (regional review, Global review, tracking of milestones as per contract). Ensure the IIS and CESR or Expanded Access Program (EAP) system for management of IIS and CESR or Expanded Access Program (EAP) review and approvals is current and accurate
    • Liaison and reporting on study activities with other relevant GOMA functions and the Global Medical Affairs Team.
    • Regional and Functional Support
      • Work with the Functional and Regional Teams and key stakeholders to drive alignment on key activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and quality
      • Establish strong partnership with Functional and Regional Operational managers to drive operational excellence with the required functions, in regions and countries for all GOMA clinical activities.
      • Process/Policies/Compliance
        • Provide input to process standards and tools to achieve excellence in trial operations and management.
        • Monitor and ensure compliance and highest quality standards in all GOMA clinical operational activities. Support the development of clinical operations related Corrective and Preventative Action (CAPA) plans for issues of non- compliance if applicableQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)
          • Bachelor's Degree or equivalent education/experience in life science/healthcare requiredExperience Qualifications
            • 4 or More Years w/M.S preferred or
            • 6+ years w/B.S. and relevant experience in pharmaceutical clinical research experience requiredTravelAbility to travel up to 20% Standard office based physical demands, minimal travel.Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Keywords: Daiichi Sankyo, Newark , Manager, GMA Clinical Trial Management & Resources, Executive , Basking Ridge, New Jersey

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