Senior Manager, External Data & CDx Programs

Daiichi Sankyo; Basking Ridge (NJ); Sur place; USD 140 000 - 180 000; Plein temps

Résumé du poste

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

Responsabilités

• 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.

Connaissances

External data management

Vendor management

CDISC SDTM

Data quality

Formation

Bachelor's degree in Life Sciences

Master's degree in Life Sciences

Description du poste

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