Program Lead, Clinical Data Strategy and Operations, Aesthetics

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) & 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.
• Education & Experience
• Must have a Bachelor's degree in Life Sciences, Information Technology, Business, or foreign education equivalent & 5 years as a clinical data scientist.
• Of work experience required, must have 5 years of each of the following:
• (i) managing data in Electronic Data Capture (EDC), Interactive Response Technology (IRT) & Clinical Trial Management System (CTMS);
• (ii) planning, coordinating, & delivering data management tasks within timeline;
• (iii) authoring, revising, & reviewing data management related plans and documentation, including Data Management Plan, Data Review Plan, Electronic Case Report Form (eCRF), & Completion Guidelines;
• (iv) utilizing project management skills including metrics analysis & reporting methodologies;
• (v) analyzing data, preparing & presenting project status & metric reports for presentation, in writing & in person, to peers & business stakeholders; &
• (vi) coaching, mentoring & delivering training to Clinical Data Management & other functions/departments as necessary.
• Of work experience required, must have 3 years reviewing data using Spotfire, J-Review, Business Objects or SAS to generate data review listings to produce data output for data cleaning in relation to clinical trials.
• Work experience may be gained concurrently.
• Salary Range: $156,832.21 - $202,500.00 per year.
• Apply online at https://careers.abbvie.com/en or send resume to Job.opportunity.abbvie@abbvie.com . Refer to Req ID: REF49754C
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• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.
• AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
• https://www.abbvie.com/join-us/reasonable-accommodations.html

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