Clinical Data Systems Architect — EDC/SDTM Expert

Allergan; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

AbbVie Data Science is seeking an experienced specialist to drive design and delivery of clinical data systems in Irvine, CA. You will implement data standards, ensure compliance with protocols, and lead cross-functional efforts across pharmacovigilance and trials.

Ideal candidates have 5+ years in EDC, with Medidata RAVE experience; strong communication and mentoring skills are essential for success in a matrixed organization.

Qualifications

• Bachelor's degree or higher in life sciences, IT, or related field; master's preferred.
• 5+ years of hands-on technical study build in EDC; Medidata RAVE is required.
• In-depth knowledge of clinical trial processes, CDASH and SDTM.
• Excellent coaching and mentoring in a matrixed environment.
• Strong written and verbal communication and analytical abilities.

Responsibilities

• Develop common data standards and ensure designs comply with standards and protocols.
• Establish and maintain methodology to design and develop clinical trial systems.
• Ensure design team consistency at TA- and program-level across work products.
• Deliver new clinical systems on time and manage integrations and changes.
• Coordinate with CDO and cross-functional partners to align objectives.
• Adhere to GCP, ICH, FDA/local SOPs and evolving regulations.
• Coach and mentor team members and drive skill development.
• Lead CDO and cross-functional innovation and process improvements.

Skills

EDC systems

Medidata RAVE

Veeva EDC

CDASH & SDTM

Regulatory knowledge

Mentoring

Education

Bachelor's degree in life sciences or IT

Masters preferred

Job description

AbbVie Data Science is seeking an experienced specialist to drive design and delivery of clinical data systems in Irvine, CA. You will implement data standards, ensure compliance with protocols, and lead cross-functional efforts across pharmacovigilance and trials.

Ideal candidates have 5+ years in EDC, with Medidata RAVE experience; strong communication and mentoring skills are essential for success in a matrixed organization.