Clinical Data Management Lead

Asklepios Biopharmaceutical, Inc. (Askbio); Durham (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

AskBio Inc. in RTP, North Carolina, seeks a Manager, Clinical Data Management to oversee DM activities across external vendors and in-house teams. You will design and program databases, oversee UAT, data review, and database locks, and ensure data integrity for sponsored trials.

The role reports to the Senior Director, Data Management and requires leadership in a matrix organization, with strong collaboration across functions to support regulatory submissions.

Qualifications

• Bachelor’s degree in life sciences 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.
• Knowledge of CDASH/SDTM standards and CDISC standards for data management and regulatory compliance.
• Ability to operate and lead in a matrix organization with diverse stakeholders.

Responsibilities

• Oversee all data management activities outsourced to external suppliers or conducted in-house, from study setup to database lock.
• Plan, coordinate, and deliver high-quality clinical trial data in a timely manner for assigned projects.
• Serve as DM point of contact for internal and external study team members with senior DM oversight.
• Provide quality and project oversight over third-party vendors responsible for DM deliverables.
• Lead content gathering for EDC and collaborate on other data collection systems.
• Represent DM on cross-functional project and submission teams.
• Support Health Authority inspections and audits.
• Manage changes to database design and data requirements due to protocol amendments.
• Develop, troubleshoot, and maintain programs for database design, validation, and analysis.
• Contribute to development of SOPs and guidance documents.

Skills

Leadership in matrix org

Regulatory understanding

Communication skills

Education

Bachelor’s degree in life sciences or related field

Tools

Veeva EDC

Medidata Rave

SAS

SQL

Power BI

Excel

Job description

AskBio Inc. in RTP, North Carolina, seeks a Manager, Clinical Data Management to oversee DM activities across external vendors and in-house teams. You will design and program databases, oversee UAT, data review, and database locks, and ensure data integrity for sponsored trials.

The role reports to the Senior Director, Data Management and requires leadership in a matrix organization, with strong collaboration across functions to support regulatory submissions.