Manager, Clinical Data Systems
AbbVie
2 hours ago
Remote friendly (Irvine, CA)
United States
Operations
Responsibilities:
- Actively participate in the development of common data standards and ensure systems designs comply with standards and associated protocol requirements.
- Establish and maintain methodology to design and develop clinical trial systems, benchmarking against industry standards.
- Specify systems to optimize functionality, end user experience, and data flow.
- Ensure TA- and program-level consistency.
- Accountable for on-time design and delivery of new clinical systems, system integrations, and required changes (e.g., EDC, IRT, ePRO). Use project management tools to track study progress and plan work; identify issues affecting timelines/quality and develop options/solutions.
- Interact with and influence DSS and cross-functional teams to achieve program and study objectives; synchronize deliverables with upstream/downstream dependencies.
- Ensure adherence to federal and local regulations, GCPs, ICH Guidelines, AbbVie SOPs, and functional quality standards; stay abreast of evolving regulations/guidelines.
- Coach and mentor team members; contribute to their skill development.
- Lead DSS and cross-functional innovation and process improvement initiatives.
Qualifications:
- Bachelor’s degree in business, management information systems, computer science, life sciences, or equivalent (Master’s preferred).
- 5+ years of clinical technology experience (e.g., EDC, IRT, ePRO) or 7+ years in a similar technical/clinical development role; experience with common industry design/development tools required.
- In-depth knowledge of clinical trial process, CDASH, and SDTM.
- Demonstrated performance as a key contributor to initiatives and organizational advancement.
- Ability to influence others without direct authority; coach/mentor in a matrixed environment; effective communication and analytical skills.
Benefits:
- Comprehensive benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible to participate in long-term incentive programs.
- Actively participate in the development of common data standards and ensure systems designs comply with standards and associated protocol requirements.
- Establish and maintain methodology to design and develop clinical trial systems, benchmarking against industry standards.
- Specify systems to optimize functionality, end user experience, and data flow.
- Ensure TA- and program-level consistency.
- Accountable for on-time design and delivery of new clinical systems, system integrations, and required changes (e.g., EDC, IRT, ePRO). Use project management tools to track study progress and plan work; identify issues affecting timelines/quality and develop options/solutions.
- Interact with and influence DSS and cross-functional teams to achieve program and study objectives; synchronize deliverables with upstream/downstream dependencies.
- Ensure adherence to federal and local regulations, GCPs, ICH Guidelines, AbbVie SOPs, and functional quality standards; stay abreast of evolving regulations/guidelines.
- Coach and mentor team members; contribute to their skill development.
- Lead DSS and cross-functional innovation and process improvement initiatives.
Qualifications:
- Bachelor’s degree in business, management information systems, computer science, life sciences, or equivalent (Master’s preferred).
- 5+ years of clinical technology experience (e.g., EDC, IRT, ePRO) or 7+ years in a similar technical/clinical development role; experience with common industry design/development tools required.
- In-depth knowledge of clinical trial process, CDASH, and SDTM.
- Demonstrated performance as a key contributor to initiatives and organizational advancement.
- Ability to influence others without direct authority; coach/mentor in a matrixed environment; effective communication and analytical skills.
Benefits:
- Comprehensive benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible to participate in long-term incentive programs.