Senior Manager, Clinical Data Systems
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is a key to ensuring successful Data collection systems delivery against the program and study-level accountabilities.
- Provides leadership, support, and influence to ensure timely and quality clinical technology deliverables across data collection and processing systems such as Electronic Data Capture (EDC), Interactive Response Technology (IRT), Electronic Clinical Outcome Assessment (eCOA) , Clinical Photography/Imaging, Clinical Data Platform (LSH).
- Leads and manages the full lifecycle of systems developed internally or by the external vendors for individual clinical trial use.
- Managing the design, development, validation, implementation, and oversees ongoing support to these systems.
- Provides strategic input into the analysis of new clinical technology vendors and capabilities in alignment with Data Science’s Clinical Technology strategy and roadmap.
- Support in the validation of electronic clinical technology systems as implemented through external vendors or developed internally according to current regulatory requirements. Supports development and implementation of departmental Standard Operating Procedures (SOPs) and work practices.
- Provides leadership and content expertise for system development activities from start‐up through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities.
- Other responsibilities include providing strategic input into the analysis of new systems and software to support clinical trials data collection, quality, and integrity.
- Lead implementation of programming standards and conventions.
- Support inspection readiness activities, as well as participate in sponsor and site inspections.
- Responsible for hiring, training, and managing performance of staff (inclusive of orientation, personal development, completing and administering performance evaluations, reward and recognition). Ensures timely hiring of qualified resources. Actively promoting empowerment and accountability within staff.
- Bachelor’s degree in business, statistics, management information systems, computer science, life sciences or equivalent is required. Master’s degree is desired.
- 3+ years of experience in clinical development in pharmaceutical or related industry
- 2+ years managing matrixed and/or direct reports
- Experience in clinical data management processes and systems
- Experience managing vendor relationship incl. governance and KPI/SLA tracking.
- Demonstrated effective communication, analytical, and leadership skills
- Experience managing clinical trials systems is required.
Significant Work Activities
Yes, 5 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.