Description
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc
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.
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.
