Manager, Clinical Trial Management - GMA Oncology - Daiichi Sankyo Inc.
Basking Ridge, NJ
About the Job
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
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._
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.
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
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._
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.
Source : Daiichi Sankyo Inc.