Data Manager II
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 key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.
- Uses understanding of clinical trial concepts and cross-functional protocol requirements to execute assigned study assignments
- Engages with members of the DSS and cross-functional study teams in order to effectively execute assigned activities
- Effectively utilizes available technology to execute assigned activities
- Develops and utilizes data standards (e.g., CDASH and SDTM), and protocol requirements in the design and development of key system interfaces and end-to-end data flow
- Creates study execution documentation including specifications, data management plan, and integrated data review plan. Executes data management plan and integrated data review plan as required by protocol and team decisions
- Triages issues as they occur and maintains required documentation per ALCOA principles. Performs data review using supplied data review tools. Performs reconciliation of data originating from different sources.
- Queries clinical sites as necessary to clarify possible data abnormalities
- If assigned, may lead process improvement efforts within Data and Statistical Sciences.
- May be assigned indirect reports during the execution of projects
- Utilizes operational data and analytical tools to optimize execution of assigned clinical trials and to identify key areas of risk that may require escalation
- Mentors junior team members
- Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards.
- Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
Level will be based on education & years of experience
- Bachelor's degree in business, management information systems, computer science, life sciences or equivalent. Master's preferred
- Must have at least 4+ year of pharmaceutical, clinical research, data management, health care or other relevant experience
- Strong understanding of clinical trial processes and clinical technology
- Demonstrated history of successful execution in a fast-paced environment and in managing multiple priorities effectively
- Demonstrated leadership traits and the ability to coach/lead in a matrix environment
- Strong understanding of GCDMP
- Demonstrated effective communication skills
- Demonstrated effective problem-solving and analytical skills