Clinical Process Specialist

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.

Job Summary:

The Clinical Process Specialist enables the analysis and optimization of clinical trial processes and SOPs through data collection, data analysis, process mapping, and process/SOP documentation. This position contributes to the deliverables/outputs of clinical process improvement and SOP teams by providing process design and documentation expertise and support.

Responsibilities:

Partners with Process Owners and Process Managers to analyze, map, and document end-to-end clinical trial processes to enable process diagnosis and optimization within a continuous process improvement framework

Identifies and documents process inputs, outputs, workflows, roles & responsibilities, and interdependencies across processes - integrates various components of process design including people, process, and technology

Provides input on how to address process gaps and inefficiencies

Collects and analyze data supporting business process analysis and optimization to support work of process improvement teams and metrics/benchmarking efforts

Consults with CRO Alliance Managers to support integration of internal processes with CRO processes and optimize touchpoints between internal and external processes

Prepares and/or reviews new or updated SOPs and training materials resulting from the work of process improvement or SOP teams

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

Bachelor's Degree in life sciences, biostatistics or related function, or business administration with minimum of 5 years of pharmaceutical or biotechnology industry experience

• Knowledge and experience in drug development in pharmaceutical and biotechnology industry
• Experience in process design and implementation including process harmonization/standardization and optimization
• Strong analytical and verbal/written communication skills including proficiency with data / process analytical and visualization tools (e.g., Visio, Power Point, Excel)
• Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements
• Six Sigma certification desired

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.

Job Title
Clinical Process Specialist

City
Basking Ridge

Functional Area
Global Clinical Operations & Planning

State
New Jersey