Manager, GMA Clinical Trial Management & Resources
Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: June 22, 2022
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
- 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
- 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
- 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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