Program Lead, Clinical Data Strategy and Operations, Aesthetics

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.

Requirements

• 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) & Clinical Trial Management Systems (CTMS).
• Have a good understanding of Laboratory data, Clinical Outcomes Assessments (COA/eCOA), Interactive Response Technology (IRT) & other external data types.
• Utilize analytical & project management tools to manage internal & external resources (including vendor oversight), track study progress, & to prepare status reports.
• Author, revise, & review data management related plans & documentation.
• Ensure adherence to current federal regulations & applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines & Standard Operating Procedures (SOPs).
• Participate in regulatory inspections & internal quality audits.
• Responsible for coaching, & mentoring team members & supervision of contract resources.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term and long-term incentive programs

Tagged as: Project Management