Clinical Data Management Lead

AskBio Inc.; Durham (NC); On-site; USD 95,000 - 150,000; Full time

Job summary

AskBio Inc. in RTP, North Carolina, seeks a Manager, Clinical Data Management to oversee data management activities for external vendors and in-house teams from study set-up through database lock, ensuring quality and integrity of all databases used in sponsored trials.

Reporting to the Senior Director of Data Management, you will lead CDASH/SDTM alignment, oversee DM plans, UAT, data review, and collaboration with cross‑functional teams, with responsibilities in vendor oversight, audits, and

Qualifications

• Bachelor’s degree in life sciences, statistics, biostatistics, mathematics, computer science, biotechnology or related field with a minimum of 6 years’ clinical trial related data management experience.
• Familiarity with clinical trial database packages such as Veeva EDC, Medidata Rave.
• Significant knowledge of the drug development process, clinical trial methodology, data management & statistics and relevant regulatory requirements for drug approval.
• Ability to operate and lead in a matrix organization with diverse expertise.

Responsibilities

• Ensure end-to-end Data Management activities meet high ethical and quality standards, all applicable GCP regulations and company procedures.
• Provide oversight of data management activities outsourced to external suppliers or conducted in-house, including DM Plan, database specification development, and UAT.
• Plan, coordinate, and deliver complete, high quality clinical trial data in a timely manner for assigned projects.
• Serve as DM point of contact for internal and external study teams with minimal senior oversight.
• Provide quality and project oversight over third‑party vendors responsible for data management deliverables.
• Lead content gathering for EDC requirements and collaborate with teams supporting other data collection systems.
• Represent DM on cross-functional project teams and submission teams.
• Support Health Authority inspections and audits.
• Manage changes to database design and DM requirements due to protocol amendments.
• Develop, troubleshoot, and maintain complex programs and utilities for database design and statistical analysis.
• Contribute to development of departmental SOPs and guidance documents.

Skills

Veeva EDC

Medidata Rave

CDASH/SDTM

SAS

SQL

Power BI

Excel

Communication

Education

Bachelor’s degree in life sciences, statistics, biostatistics, mathematics, computer science, biotechnology or related field

Tools

SAS

SQL

Power BI

Job description

AskBio Inc. in RTP, North Carolina, seeks a Manager, Clinical Data Management to oversee data management activities for external vendors and in-house teams from study set-up through database lock, ensuring quality and integrity of all databases used in sponsored trials.

Reporting to the Senior Director of Data Management, you will lead CDASH/SDTM alignment, oversee DM plans, UAT, data review, and collaboration with cross‑functional teams, with responsibilities in vendor oversight, audits, and