Clinical Trial Manager, Global Oncology Medical Affairs

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Summary

Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored Studies (CSS) and Medical Access/Expanded Access (MAP)/(EAP)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 ManagementCompany Sponsored Studies (CSS)

• Support the preparation, set-up, and execution and reporting of all Global Oncology Medical Affairs operations 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.Company Sponsored Studies (CSS) and Medical Access/Expanded Access Program (MAP)/(EAP)
• Support the oversight of the overall Global Oncology review process of PhIV company sponsored studies per the Standard Operating Procedure (SOP) (regional review, Global review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies review and approvals are 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 to Corrective and Preventative Action (CAPA) plans for issues of non-compliance if applicable.

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 required Experience Qualifications

Experience Qualificaitons

• 4 or More Years overall related experience or commensurate education/experience required
• Medical Affairs experience preferred
• Project Management experience preferred
• Ability 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.