Program Lead, Clinical Data Strategy and Operations, Aesthetics
AbbVie
4 months ago
Remote friendly (North Chicago, IL)
United States
Operations
Key Responsibilities:
- Align & coordinate Data & Statistical Science (DSS) study teams with program & study-level strategies to meet operational objectives.
- Lead DSS Study Team; represent DS as a member of cross-functional study team.
- Utilize clinical trial systems including Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS).
- Understand Laboratory data, Clinical Outcomes Assessments (COA/eCOA), Interactive Response Technology (IRT) and other external data types.
- Use analytical & project management tools to manage internal/external resources (including vendor oversight), track study progress, and prepare status reports.
- Author, revise, and review data management related plans & documentation.
- Ensure adherence to federal/local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Standard Operating Procedures (SOPs).
- Participate in regulatory inspections and internal quality audits.
- Coach, mentor team members, and supervise contract resources.
Qualifications:
- Bachelor’s degree in Life Sciences, Information Technology, Business (or foreign equivalent) and 5 years as a clinical data scientist.
- 5 years each of: (i) managing data in EDC/IRT/CTMS; (ii) planning/coordinating/delivering data management tasks within timeline; (iii) authoring/revising/reviewing data management plans & documentation (Data Management Plan, Data Review Plan, eCRF, Completion Guidelines); (iv) project management with metrics analysis & reporting; (v) analyzing data and preparing/presenting project status & metric reports to stakeholders; (vi) coaching/mentoring and delivering training to Clinical Data Management and other functions.
- 3 years reviewing data using Spotfire, J-Review, Business Objects, or SAS to generate data review listings for clinical trial data cleaning.
- Work experience may be gained concurrently.
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) to eligible employees; eligible for short-term and long-term incentive programs.
Application Instructions:
- Apply online at https://careers.abbvie.com/en or send resume to Job.opportunity.abbvie@abbvie.com. Refer to Req ID: REF49754C.
- Align & coordinate Data & Statistical Science (DSS) study teams with program & study-level strategies to meet operational objectives.
- Lead DSS Study Team; represent DS as a member of cross-functional study team.
- Utilize clinical trial systems including Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS).
- Understand Laboratory data, Clinical Outcomes Assessments (COA/eCOA), Interactive Response Technology (IRT) and other external data types.
- Use analytical & project management tools to manage internal/external resources (including vendor oversight), track study progress, and prepare status reports.
- Author, revise, and review data management related plans & documentation.
- Ensure adherence to federal/local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Standard Operating Procedures (SOPs).
- Participate in regulatory inspections and internal quality audits.
- Coach, mentor team members, and supervise contract resources.
Qualifications:
- Bachelor’s degree in Life Sciences, Information Technology, Business (or foreign equivalent) and 5 years as a clinical data scientist.
- 5 years each of: (i) managing data in EDC/IRT/CTMS; (ii) planning/coordinating/delivering data management tasks within timeline; (iii) authoring/revising/reviewing data management plans & documentation (Data Management Plan, Data Review Plan, eCRF, Completion Guidelines); (iv) project management with metrics analysis & reporting; (v) analyzing data and preparing/presenting project status & metric reports to stakeholders; (vi) coaching/mentoring and delivering training to Clinical Data Management and other functions.
- 3 years reviewing data using Spotfire, J-Review, Business Objects, or SAS to generate data review listings for clinical trial data cleaning.
- Work experience may be gained concurrently.
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) to eligible employees; eligible for short-term and long-term incentive programs.
Application Instructions:
- Apply online at https://careers.abbvie.com/en or send resume to Job.opportunity.abbvie@abbvie.com. Refer to Req ID: REF49754C.