Senior Clinical Data Systems Architect

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

Benefits offered by this job

Medical/Dental/Vision insurance

401(k) plan

Paid time off

Job summary

AbbVie Data Science is seeking an experienced professional to drive design and delivery of clinical data systems within the Clinical Data Strategy Organization. You will contribute to data standards, optimize trial data flows, and coordinate with CDO and cross-functional teams to meet study objectives.

The role requires advanced knowledge of EDC (Medidata RAVE), CDASH/SDTM, and strong mentorship abilities to develop team skill sets and process improvements.

Qualifications

• Bachelor's degree in business, MIS, CS, life sciences or equivalent.
• 5+ years of hands-on technical Study build in EDC; Medidata RAVE required; Veeva EDC a plus.
• In-depth knowledge of clinical trial processes.
• In-depth knowledge of CDASH and SDTM.
• Proven ability to influence others and coach in a matrixed environment.

Responsibilities

• Participates in developing common data standards and ensures design aligns with standards and protocols.
• Designs and develops clinical trial systems; benchmark against industry standards; optimize functionality and data flow.
• Ensures TA- and program-level consistency across the design team.
• Delivers on-time design and delivery of new clinical systems and integrations; tracks progress and risks.
• Interacts with CDO and cross-functional teams to align objectives and dependencies.
• Adheres to GCP, applicable regulations, AbbVie SOPs and quality standards; stays updated on policies.
• Coaches and mentors team members and leads process improvement initiatives.

Skills

Communication skills

Mentoring / Coaching

Analytical skills

Influence without authority

Cross-functional collaboration

Education

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

Masters preferred

Tools

Medidata RAVE

Veeva EDC

Job description

AbbVie Data Science is seeking an experienced professional to drive design and delivery of clinical data systems within the Clinical Data Strategy Organization. You will contribute to data standards, optimize trial data flows, and coordinate with CDO and cross-functional teams to meet study objectives.

The role requires advanced knowledge of EDC (Medidata RAVE), CDASH/SDTM, and strong mentorship abilities to develop team skill sets and process improvements.