Clinical Data Management Lead for Gene Therapy Trials

Asklepios Biopharmaceutical Inc; Durham (NC); On-site; USD 90,000 - 135,000; Full time

Job summary

AskBio Inc., a Bayer subsidiary, is seeking a Manager of Clinical Data Management to lead end-to-end data management for clinical trials at its RTP, North Carolina site. The role oversees external and in-house DM activities, including DMPs, database design, UAT, data review, coding, and database locks, ensuring data integrity and quality.

The position requires at least 6 years in clinical trial data management, strong CDASH/CDISC knowledge, and familiarity with Veeva EDC and Medidata Rave, with

Qualifications

• Bachelor’s degree in life sciences, statistics, biostatistics, mathematics, computer science or related field.
• At least 6 years of clinical trial data management experience.
• Strong knowledge of CDASH/CDISC standards and SDTM mapping.
• Experience with Veeva EDC and Medidata Rave is preferred.

Responsibilities

• Oversee end-to-end data management for outsourced and in-house studies.
• Develop and maintain Data Management Plan and DB specifications.
• Coordinate UAT, data review, coding, and database locks.
• Support Health Authority inspections and audits.
• Lead cross-functional DM activities within a matrix organization.

Skills

Data management

Leadership

SAS

SQL

Power BI

Excel

CDASH

CDISC SDTM

Regulatory knowledge

GCP

Education

Bachelor's degree

Tools

Veeva EDC

Medidata Rave

Job description

AskBio Inc., a Bayer subsidiary, is seeking a Manager of Clinical Data Management to lead end-to-end data management for clinical trials at its RTP, North Carolina site. The role oversees external and in-house DM activities, including DMPs, database design, UAT, data review, coding, and database locks, ensuring data integrity and quality.

The position requires at least 6 years in clinical trial data management, strong CDASH/CDISC knowledge, and familiarity with Veeva EDC and Medidata Rave, with