Program Lead, Clinical Data Strategy and Operations, Aesthetics

Company Description

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. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description

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) & 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.

Qualifications

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.

Additional Information

Salary Range: $156,832.21 - $202,500.00 per year.

Apply online at or send resume to [email protected] . 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 committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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.

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