Senior External Data Management Lead for Clinical Trials

HireLifeScience; Basking Ridge (NJ); On-site; USD 127,000 - 191,000; Full time

Job summary

Daiichi Sankyo, Inc. seeks a Manager External Data Management to oversee end-to-end external data delivery for clinical trials and regulatory submissions.

You will collaborate with Clinical Operations, Biomarkers, QA, and external vendors to ensure timely, compliant data delivery across programs. Must have 5+ years in external data management and strong CDISC/SDTM knowledge; experience with vendor oversight and data transfer specifications is required for success in a fast-paced global

Qualifications

• 5+ years of experience in External data management and data transfer oversight.
• 2+ years of Clinical data management experience in pharma/medical device sectors.
• Knowledge of CDISC/SDTM standards and data collection practices.

Responsibilities

• Lead data management activities for external data transfers with CDx partners and vendors.
• Ensure SDTM alignment and data transfer specifications across DS programs.
• Support inspection readiness and data quality across trials and regulatory submissions.

Skills

External data management

CDISC/SDTM knowledge

Vendor management

Education

Bachelor's degree in Life Sciences or related field

Master's degree in Life Sciences or related field

RN in Life Sciences or related field

Job description

Daiichi Sankyo, Inc. seeks a Manager External Data Management to oversee end-to-end external data delivery for clinical trials and regulatory submissions.

You will collaborate with Clinical Operations, Biomarkers, QA, and external vendors to ensure timely, compliant data delivery across programs. Must have 5+ years in external data management and strong CDISC/SDTM knowledge; experience with vendor oversight and data transfer specifications is required for success in a fast-paced global