Manager, Clinical Data Systems
AbbVie
2 hours ago
Remote friendly (Florham Park, NJ)
United States
IT
Responsibilities:
- Actively participate in the development of common data standards; ensure systems designs comply with standards and associated protocol requirements; ensure design team utilizes standards.
- 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 design team meets expectations.
- Ensure TA- and program-level consistency.
- Accountable for on-time design and delivery of new clinical systems, system integrations, and required changes to clinical systems (e.g., EDC, IRT, ePRO); use project management tools to track study progress and plan work; anticipate/identify issues affecting timelines or quality and develop options/solutions.
- Interact with and influence DSS and cross-functional team members to achieve program and study objectives; ensure work products are synchronized with upstream/downstream dependencies.
- Ensure adherence to federal and local regulations, GCPs, ICH guidelines, AbbVie SOPs, and functional quality standards; stay abreast of evolving local regulations, guidelines, and policies.
- 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 or clinical development role; experience with common industry design and development tools required.
- In-depth knowledge of clinical trial process, including CDASH and SDTM.
- Demonstrated performance as a key contributor to initiatives and organizational advancement.
- Ability to influence others without direct authority; ability to coach/mentor in a matrixed environment; effective communication and analytical skills.
- Actively participate in the development of common data standards; ensure systems designs comply with standards and associated protocol requirements; ensure design team utilizes standards.
- 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 design team meets expectations.
- Ensure TA- and program-level consistency.
- Accountable for on-time design and delivery of new clinical systems, system integrations, and required changes to clinical systems (e.g., EDC, IRT, ePRO); use project management tools to track study progress and plan work; anticipate/identify issues affecting timelines or quality and develop options/solutions.
- Interact with and influence DSS and cross-functional team members to achieve program and study objectives; ensure work products are synchronized with upstream/downstream dependencies.
- Ensure adherence to federal and local regulations, GCPs, ICH guidelines, AbbVie SOPs, and functional quality standards; stay abreast of evolving local regulations, guidelines, and policies.
- 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 or clinical development role; experience with common industry design and development tools required.
- In-depth knowledge of clinical trial process, including CDASH and SDTM.
- Demonstrated performance as a key contributor to initiatives and organizational advancement.
- Ability to influence others without direct authority; ability to coach/mentor in a matrixed environment; effective communication and analytical skills.