Clinical Data Systems Architect II

Allergan; Florham Park (NJ); On-site; USD 110,000 - 165,000; Full time

Job summary

AbbVie is seeking an experienced data systems professional to lead design and delivery of clinical data systems. You will ensure standards compliance, drive end-to-end EDC/IRT/ePRO integrations, and align with program objectives across cross‑functional teams.

The role requires 5+ years in hands-on EDC development, with Medidata RAVE experience; Veeva EDC a plus. Strong CDASH/SDTM knowledge and excellent communication are essential.

Qualifications

• Bachelor’s degree in business, MIS, CS, life sciences or equivalent; Masters preferred.
• 5+ years of hands-on EDC study build experience; Medidata RAVE required; Veeva EDC a plus.
• Strong knowledge of CDASH and SDTM.
• Proven ability to influence others in a matrixed environment; coach/mentor capabilities.
• Excellent communication and analytical skills.

Responsibilities

• Develop common data standards and ensure systems designs comply with standards and protocols.
• Design and develop clinical trial systems to optimize function, UX and data flow.
• Ensure TA- and program-level consistency across the design team.
• Deliver on-time design and integrations for new clinical systems (EDC/IRT/ePRO).
• Collaborate with CDO and cross-functional teams to align objectives and dependencies.
• Adhere to GCP, ICH guidelines and AbbVie SOPs; stay updated on regulatory changes.
• Coach and mentor team members and lead process improvement initiatives.

Education

Bachelor’s degree in business, MIS, CS, life sciences or equivalent; Masters preferred.

Tools

Medidata RAVE

Veeva EDC

Job description

AbbVie is seeking an experienced data systems professional to lead design and delivery of clinical data systems. You will ensure standards compliance, drive end-to-end EDC/IRT/ePRO integrations, and align with program objectives across cross‑functional teams.

The role requires 5+ years in hands-on EDC development, with Medidata RAVE experience; Veeva EDC a plus. Strong CDASH/SDTM knowledge and excellent communication are essential.