CASY-MSCCN Jobs

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 www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Key Responsibilities

• Align Data & Statistical Science (DSS) study teams with program & study-level strategies.

• Lead the DSS Study Team & represent DSS as a member of cross-functional study team.

• Act as single point of contact & accountable operational lead from DSS. Coordinates associated DSS study teams to meet operational objectives.

• Utilize clinical trial systems including Electronic Data Capture (EDC), Interactive Response Technology (IRT) & Clinical Trial Management Systems (CTMS).

• Utilize understanding of Laboratory data, Clinical Outcomes Assessments (COA/eCOA), ECG, IRT, Pharmocokinetic & other external data types.

• Engage & connect global functional & cross-functional teams at study level. Interact with & influence cross-functional team members to achieve program objectives.

• Plan, coordinate, & deliver data management tasks within timeline.

• Utilize operational analytics & project management tools to optimize execution of programs & studies, manage internal & external resources, track study progress, & prepare study status reports.

• Author, revise, & review data management related plans & documentation, including Data Management Plan, Data Review Plan, Electronic Case Report Form (eCRF), & completion Guidelines.

• Anticipate & identify issues that could affect timelines or quality & develop options & solutions, identify & mitigate risk and contribute to Risk Assessment & Management Plan.

• Ensure adherence to federal regulations & applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), & functional quality standards.

• Perform project management skills including metrics analysis & reporting methodologies.

• Keep abreast of new &/or evolving local regulations, guidelines & policies related to clinical development.

• Participate as DSS study owner in regulatory inspections & internal quality audits.

• Participate in oversight of vendors & provide feedback related to clinical trial operations, issues, & trends in performance.

• Utilize reporting & data visualization tools such as Spotfire, J-Review, Business Objects &/or SAS to generate data review listings, also, project management tools such as Microsoft Project, Smartsheet or equivalent.

• Responsible for coaching & mentoring team members.

• Lead DSS innovation & process improvement initiatives & participates in cross-functional initiatives.

• Conduct study execution across functions.

• Conduct indirect supervision of employees as well as supervision of work of contract resources.

Qualifications

Must possess a Bachelor’s degree or foreign academic equivalent in Biology, Biotechnology, Information Technology, Business, or a related field of study with at least 2 years of experience in the following:

• Electronic Data Capture (EDC), Interactive Response Technology (IRT) & Clinical Trial Management System (CTMS);

• planning, coordinating, & delivering data management tasks within timeline;

• authoring, revising, & reviewing data management related plans & documentation, including Data Management Plan, Data Review Plan, Electronic Case Report Form (eCRF), and Completion Guidelines;

• project management skills including metrics analysis & reporting methodologies; &

• Spotfire, J-Review, Business Objects &/or SAS to generate data review listings.

Position requires work at various & unanticipated work locations throughout the U.S. 100% telecommuting permissible.

Apply online at https://careers.abbvie.com/en. Refer to Req ID: REF23193M.

Additional Information

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.