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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Aligns DSS study teams with program- and study-level strategies. Assigned programs may include programs that are oflow complexity and size. For assigned programs and studies, leads the DSS Study Team and represents DS as amember of the cross-functi onal study team For assigned programs and studies, acts as single point of contact andaccountable operati onal lead from DSS. Coordinates associated DSS study teams to meet operati onal objecti ves.Engages and connects global functi onal and cross-functi onal teams at the study level Interacts with and infl uencescross-functi onal team members to achieve program objecti ves Uti lizes operati onal analyti cs and project managementtools to opti mize executi on of programs and studies, to manage internal and external resources, to track studyprogress, and to prepare study status reports. Anti cipates and identi fi es issues that could aff ect ti melines or qualityand develops opti ons and soluti ons Ensures adherence to federal regulati ons and applicable local regulati ons, GoodClinical Practi ces (GCPs), ICH Guidelines, AbbVie Standard Operati ng Procedures (SOPs), and to functi onal qualitystandards. Stays abreast of new and/or evolving local regulati ons, guidelines and policies related to clinicaldevelopment. If assigned, parti cipates as the DS study owner in regulatory inspecti ons and internal quality auditsParti cipates in oversight of vendors and provides feedback related to clinical trial operati ons, issues, and trends inperformance Responsible for coaching and mentoring team members Leads DSS innovati on and processimprovement initi ati ves and parti cipates in cross-functi onal initi ati ves Conducts study executi on “lessons learned”across functi ons May include indirect supervision of employee as well as supervision of work of contract resources
Qualifications
Bachelor’s degree in business, management informati on systems, computer science, life sciences or equivalent.Master’s preferred. PMP Certi fi cati on or Lean Six Sigma Green Belt desired. Must have 6+ years of pharma / clinicalresearch / data management / health care experience or 8+ years of project management experience (and / orapplicable work experience). In-depth understanding of clinical trial processes and clinical technology. Managementof a clinical trial from initi ati on through to completi on in a lead role is preferred Demonstrated performance as afuncti onal leader Demonstrated ability to infl uence others without direct authority Demonstrated ability tosuccessfully coach / mentor in a matrix environment Demonstrated eff ecti ve communicati on skills Demonstratedeff ecti ve analyti cal skills
Additional Information
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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