Senior Manager, External Data & CDx Programs

Daiichi Sankyo; Basking Ridge (NJ); On-site; USD 140,000 - 180,000; Full time

Job summary

Daiichi Sankyo in the United States seeks a Manager External Data Management to lead end-to-end external data delivery for clinical trials and regulatory submissions. You will partner with Clinical and Medical teams, vendors, and CDx programs to ensure data standards, quality, and timely data transfers.

The role requires extensive experience in data management, CDISC/SDTM knowledge, and vendor management. You will oversee documentation, QA, and inspection readiness while driving continuous

Qualifications

• Bachelor's degree in Life Sciences or related field (or equivalent experience) Required
• Master's degree in Life Sciences or related field (or equivalent experience) Preferred
• RN in Life Sciences or related field (or equivalent experience) Preferred

Responsibilities

• Lead external data collection requirements across DS Programs.
• Collaborate with cross-functional stakeholders on data standards and data cleaning.
• Ensure quality delivery of external data from vendors and labs.
• Support regulatory submissions data delivery and trial data management.
• Maintain EFTs/eDTS alignment and data transfer specifications.

Skills

External data management

Vendor management

CDISC SDTM

Data quality

Education

Bachelor's degree in Life Sciences

Master's degree in Life Sciences

Job description

Daiichi Sankyo in the United States seeks a Manager External Data Management to lead end-to-end external data delivery for clinical trials and regulatory submissions. You will partner with Clinical and Medical teams, vendors, and CDx programs to ensure data standards, quality, and timely data transfers.

The role requires extensive experience in data management, CDISC/SDTM knowledge, and vendor management. You will oversee documentation, QA, and inspection readiness while driving continuous