External Data Management Lead

Initial Therapeutics, Inc.; Basking Ridge (NJ); On-site; USD 127,000 - 191,000; Full time

Job summary

Daiichi Sankyo, Inc. is seeking a Manager of External Data Management to lead end-to-end data delivery from third-party sources for global drug development and submissions.

This role partners with Clinical Operations, Biomarkers, and CROs to assure data quality, standards, and timely delivery across studies. Ideal candidates have 5+ years in external data management with CDISC/SDTM expertise, strong vendor management skills, and a track record of ensuring data integrity for regulatory filings.

Qualifications

• Bachelor’s degree in Life Sciences or related field required.
• 2+ years of clinical data management experience in pharma/CRO environment.
• Strong knowledge of CDISC/SDTM and vendor oversight required.

Responsibilities

• Lead end-to-end external data collection and delivery across programs.
• Oversee data transfer specifications and vendor relationships.
• Ensure data quality and compliance with EFTs and eDTS.
• Support inspections and regulatory submissions with data deliverables.

Skills

External data management

Vendor management

CDISC/SDTM

Clinical data management

Regulatory compliance

Education

Bachelor's degree in Life Sciences

Master's degree in Life Sciences

RN credential

Tools

EDC systems

CDMS / data platforms

Job description

Daiichi Sankyo, Inc. is seeking a Manager of External Data Management to lead end-to-end data delivery from third-party sources for global drug development and submissions.

This role partners with Clinical Operations, Biomarkers, and CROs to assure data quality, standards, and timely delivery across studies. Ideal candidates have 5+ years in external data management with CDISC/SDTM expertise, strong vendor management skills, and a track record of ensuring data integrity for regulatory filings.