Senior Manager, Clinical Data Systems: Lead SDTM/CDASH

BioSpace; North Chicago (IL); On-site; USD 110,000 - 170,000; Full time

Job summary

AbbVie is seeking a senior data science professional to lead clinical data programs, including database design, data loading, and SDTM/CDASH alignment. You will drive process improvements, mentor staff, and collaborate across therapeutic areas to ensure high-quality deliverables.

The role emphasizes cross-functional leadership, vendor oversight, and strategic direction for data initiatives within a global pharmaceutical context.

Qualifications

• Bachelor’s degree in management information systems, computer science, life sciences or equivalent. Master’s preferred.
• Must have 8+ years of experience with clinical database design, data loading, and database modeling concepts OR 9+ years in a similar technical or clinical development environment.
• Demonstrated intermediate SAS and/or SQL programming skills and expert knowledge of database concepts.
• In-depth knowledge of CDASH and SDTM Standards In-depth understanding of clinical trial processes
• Demonstrated ability to influence others without direct authority. Demonstrated performance as a key contributor to initiatives and advancement of the organization. Demonstrated ability to successfully coach/mentor in a matrix environment Demonstrated effective communication skills Demonstrated effective analytical skills

Responsibilities

• Manage multiple TA.
• Manage technology evaluations and implementations for performance improvement and cost reduction.
• Creates and sustains an environment that attracts, develops and retains strong talent.
• Practice continuous improvement of processes and technology usage.
• Acts as subject matter expert and process owner.
• Supervises and allocates internal and external resources within the Therapeutic Area.
• Ensure all performance assessment responsibilities are achieved for direct reports. Provide training and feedback, resolve personnel issues, and manage talent retention for assigned staff.
• Responsible for the performance management of staff; supporting team in building and maintaining a high performing team, recruitment, onboarding, resource assignment, and development opportunities for staff within responsibility.
• Manage cross functional initiatives.
• Provides strategic direction, advice and guidance to staff in relation to operations responsibilities and activities; promotes best practice; ensures objectives are successfully met.
• Oversee vendor deliverables and ensure SDTM deliverables meet established quality standards, submission requirements, and applicable regulatory expectation

Skills

SAS programming

SQL programming

CDASH standards

SDTM standards

Clinical trial processes

Influence without authority

Communication skills

Analytical skills

Education

Bachelor’s degree in MIS / CS / life sciences or equivalent

Master’s degree preferred

Job description

AbbVie is seeking a senior data science professional to lead clinical data programs, including database design, data loading, and SDTM/CDASH alignment. You will drive process improvements, mentor staff, and collaborate across therapeutic areas to ensure high-quality deliverables.

The role emphasizes cross-functional leadership, vendor oversight, and strategic direction for data initiatives within a global pharmaceutical context.