AbbVie Clinical Data Strategy and Operations is the best-in-class team within its cross-industry peer group. We are 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 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; Deep knowledge about RAVE Architect, CDISC and SDTM Standards are required.
- 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.
- Leads the execution of all processes in support of study startup, conduct and close-out.
- 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.
- 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. Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Participates in DSS and cross-functional innovation and process improvement initiatives
- Aligns DSS study teams with study-level strategies. For assigned studies, leads the DSS Study Team and represents DS as a member of the cross-functional study team.
- Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions.
- Responsible for all DS project activities for in DS for all assigned trials.
- Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred.
- Must have at least 4+ years 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 effective problem-solving and analytical skills
- Demonstrated leadership traits and the ability to coach/lead in a matrix environment
- Strong understanding of GCDMP
- Excellent command in English, German would be a plus
Job Type: Experienced