Clinical Data Systems Architect (EDC/RAVE)

Allergan; Florham Park (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie Data Science is seeking a seasoned professional to lead and deliver complex clinical data systems in support of the Clinical Data Strategy Organization. You will drive study builds, ensure regulatory compliance, and collaborate with cross-functional teams.

The role requires extensive hands-on EDC experience (Medidata RAVE, Veeva EDC), strong CDASH/SDTM knowledge, and mentoring capabilities in a fast-paced environment within the AbbVie ecosystem.

Qualifications

• Bachelor’s degree required; Masters preferred.
• 5+ years hands-on technical study build in EDC.
• Experience with Medidata RAVE and Veeva EDC is valuable.
• In-depth knowledge of clinical trial processes (CDASH/SDTM).
• Proven ability to influence and mentor in a matrixed environment.
• Strong communication and analytical skills.

Responsibilities

• Actively participates in developing data standards and ensures designs meet protocol requirements.
• Establishes and maintains study design methodology for clinical systems.
• Ensures consistency across TA and program-level designs.
• Leads on-time design and delivery of new clinical systems and integrations.
• Interacts with CDO and cross-functional teams to align objectives.
• Adheres to GCPs and regulatory requirements and maintains quality standards.
• Coaches and mentors team members and drives innovation.
• Leads process improvement initiatives in the organization.

Skills

5+ years EDC

Medidata RAVE

Veeva EDC

CDASH

SDTM

Communication skills

Mentoring

Education

Bachelor’s degree in business/MIS/CS/life sciences

Tools

Medidata RAVE

Veeva EDC

Job description

AbbVie Data Science is seeking a seasoned professional to lead and deliver complex clinical data systems in support of the Clinical Data Strategy Organization. You will drive study builds, ensure regulatory compliance, and collaborate with cross-functional teams.

The role requires extensive hands-on EDC experience (Medidata RAVE, Veeva EDC), strong CDASH/SDTM knowledge, and mentoring capabilities in a fast-paced environment within the AbbVie ecosystem.