Senior Clinical Data Systems Designer (EDC/SDTM)

Spectraforce Technologies, Inc.; Avon-by-the-Sea (NJ); On-site; USD 120,000 - 150,000; Full time

Job summary

AbbVie is seeking a Senior Clinical Data Systems Specialist to lead standardization and design of clinical trial systems. You will ensure compliance with CDASH/SDTM and drive data quality and integration across EDC platforms.

Responsibilities include establishing common data standards, mentoring team members, coordinating with CDO and cross-functional partners, and delivering timely system designs in alignment with regulatory requirements.

Qualifications

• Bachelor's degree in business, MIS, computer science, life sciences or equivalent. Masters preferred.
• 7+ years of hands-on technical Study build in EDC.
• Experience with Medidata RAVE is required.
• Veeva EDC experience is a plus.
• In-depth knowledge of CDASH and SDTM.
• Strong communication and mentoring skills.
• Ability to influence others without direct authority.

Responsibilities

• Develop and enforce common data standards for clinical trial systems.
• Ensure designs comply with standards, protocols, and regulatory requirements.
• Lead on-time design and delivery of new clinical systems and integrations.
• Mentor team members and drive process improvements.
• Coordinate with CDO and cross-functional teams to achieve objectives.
• Track progress using project management tools and manage timelines.

Skills

Data standards

Project coordination

Communication

Leadership

Education

Bachelor's degree in business, MIS, CS, life sciences or equivalent

Master's degree preferred

Tools

Medidata RAVE

Veeva EDC

Electronic Data Capture (EDC)

CDASH tooling

Job description

AbbVie is seeking a Senior Clinical Data Systems Specialist to lead standardization and design of clinical trial systems. You will ensure compliance with CDASH/SDTM and drive data quality and integration across EDC platforms.

Responsibilities include establishing common data standards, mentoring team members, coordinating with CDO and cross-functional partners, and delivering timely system designs in alignment with regulatory requirements.