Manager, Evidence Generation Data Management

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 120 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. 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.

Summary

• The position holder will manage, with direction, end-to-end delivery of data management services for assigned studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget.
• The position holder will partner with internal and external stakeholders to optimize Data Management technology, processes, and standards.
• The position will have a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received from CROs and other third-party vendors.
• The position holder may act as a Biometrics Project Manager to plan and coordinate cross functional Evidence Generation execution of the study deliverables
  
  
  

Responsibilities

Study Responsibility

• Responsible, with supervision, for study activities assigned related to the Data Management study set up, conduct, and close out. Ensure timely, to budget and accurate completion of Data Management deliverables, including but not exclusive to the Data Management Plan
• Database specifications, Database build, interim data cuts, Database lock and study archiving
• Leads the data review process in collaboration with the study team to ensure data quality
• Contribute, with supervision, to documents submitted to Regulatory or Pricing Authorities.
• Must comply with international regulations
• Ensure inspection readiness as well as prepare potential audits linked to assigned studies
  
  
  

Vendor Oversight

• Under supervision, responsible for routine oversight of vendor delivery , to ensure compliance with the protocol, external/internal standards applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.
• Participates in drafting request for proposal for CRO selection. Reviews base-line budget and timelines. Contributes to budget management and activities across the project duration
  
  
  

Operational Excellence

• Participate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions
• Maintains current knowledge of industry best practice in Data Management methodology, Data Integrity, and Data Privacy
• Any other duties deemed pertinent to the needs of the business
  
  
  

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 or an equivalent combination of education and experience preferred
  
  
  

Experience Qualifications

• At least 4 or More Years of experience supporting drug development and/or post marketing in Clinical Research, Pharmaceutical, CRO or Medical Device setting
• Or
• At least 7 or More Years of experience supporting drug development and/or post marketing in Clinical Research, Pharmaceutical, CRO or Medical Device setting, in lieu of Bachelor’s Degree required
• Experience in oncology Therapeutic Area and/or in late phase projects is an advantage
• Good communication skills, both oral and written, in explaining in simple terms complex concepts
• Solid understanding of Data Integrity and GDPR principles
• Thorough knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research.
• Fundamental negotiation and project management skills
• Ability and interest to work remotely with worldwide team members across cultures and time zones
  
  
  

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.