Analyst, Evidence Generation Data Management

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Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.

Summary

• The position holder will support 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 support the study lead and partner with internal and external stakeholders to optimize Data Management technology, processes, and standards.
• The position will understand Electronic Data Capture/related applications and industry standards, and fundamental technical skills in working with data received from CROs and other third-party vendors.
  
  
  

Responsibilities

• Study Responsibilities:
• Responsible, with strict 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
• Must comply with international regulations, with guidance under Manager
• Ensure inspection readiness, as well as prepare potential audits linked to assigned studies
• Vendor Oversight:
• With 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.
• Operational Excellence:
• Participate, with supervision, 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 supporting duties deemed pertinent to the needs of the business (included but not limited to: town halls meetings coordination)
  
  
  

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 Related Sciences preferred
• Experience Qualifications
• 1 or More Years experience supporting drug development and 1 or More Years experience supporting post marketing in clinical research, Pharmaceutical, CRO or Medical Device setting, required or
• 4 or More Years supporting drug development, post marketing in clinical research, Pharmaceutical, CRO or Medical Device required, in lieu of Bachelor's Degree required
  
  
  

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.