Associate Director, Clinical Trial Operational Risk

1 month ago

Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full time

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 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.

Summary

The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will be responsible for lifecycle management of GCO Risks and issues and ownership (design RM oversight tools, management, and maintenance), and provide day-to-day operational risk support to study teams and their line management to ensure prevention of issues, early identification of issues, and provide expert advice on identification of root causes and support development of Correction Action/Preventive Action (CAPA) plans and related effectiveness measures, as appropriate.

Responsibilities:

Clinical Trial Operational Risk Management:

  • Own, lead and manage GCO Risk Management Plans (RMPs) (design, management, and maintenance) for global clinical trials.
  • Provide day-to-day support to study teams and their line management to ensure prevention of issues, early identification of issues, and provide expert advice on identification of root causes and support development of Correction Action/Preventive Action (CAPA) plan and related effectiveness measures.
  • Ensures appropriate oversight from a clinical trial risk and compliance standpoint and establishes a comprehensive interface for risk and issue management with strategic development partners.
  • As needed, involved in due diligence activities during the vendor selection process.
  • Support establishment of and/or build CTOR processes and tools, as needed, to assist the GCO organization.
  • In close collaboration with strategic development partners (Strategic Vendor Oversight (SVO), Alliance Management, CQM, GCO), supports the development of robust vendor management oversight plans and establishes a comprehensive interface for risk and issue management.
  • Support GCO Quality by Design, risk management, issue management, and root cause analyses.
  • As needed, may be involved in due diligence activities during the vendor selection process.
  • Close partnership with clinical quality management, SVO and other compliance functions within and outside of GDO, global process owners, and other support functions, to ensure a community of practice centered on Quality by Design, Clinical Trial Risk Management, efficient Issue Management, and Continuous Improvement.

Metrics and Collaboration Opportunities:

  • For internal audits and Health Authority inspections, provide support, as needed, to the central study teams in collaboration with CQM to ensure the timely development of CAPA responses to promote a continuous improvement of identified issues.
  • Provide support to objectives, workstreams, and strategic imperatives, as needed.
  • When needed, collaborate with CTBO, CQM, AM, and SVO to develop/provide input into metrics to help track and oversee the progress of clinical trial risks at both a study and aggregate level to monitor and evaluate risks/issues across GCO and effectiveness of initiative and/or process implementation.
  • Monitor key risk metrics and partner with SMEs to identify and address gaps/deficiencies


Qualifications:
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 Bachelor's degree with minimum of 10 years' experience in pharmaceutical or biotechnology across clinical trial operations. Experience in training, process improvement, and project management a plus. required Experience Qualifications
  • Strong experience and expertise in end-to-end clinical operations functional understanding and execution, including experience in clinical trial/protocol design and implementation required
  • Additional experience and expertise in end-to-end clinical trial execution in one or more key functions (e.g. clinical research & development, clinical science, clinical quality assurance, project management) required
  • Strong leadership, collaboration, influencing, and change management skills in a complex, matrix environment including team leadership or project management required
  • Additional experience in process improvement activities and implementation required
  • Understanding of regulatory and industry guidance trends with ability to apply them to risk management improvements required

Travel:
 Ability to travel up to 10% For team meetings, conference, and to support inspection.

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.

Estimated Salary: $20 to $28 per hour based on qualifications.

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