This role can be hired at a PL Ior a PL II level, dependent on years of relevant experience; previous work, education, training, and clinical research capabilities

AbbVie Clinical Data strategy and Operations (CDSO) is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences (DSS).

• Represents DSS as the CDSO Program Lead within the cross-functional study team; aligning study teams with program and study-level strategies from the CDSO perspective.
• Provides expertise on Data Management ensuring quality and timely delivery of all CDSO deliverables
• For assigned programs and studies, the CDSO PL acts as single point of contact and is accountable for data management activities and timelines, collaborating with the cross-functional teams as needed.
• Responsible for ensuring the quality of all CDSO deliverables; working in conjunction with our clinical technology teams and external partners (e.g.  clinical database development (e.g. EDC, IRT, eCOA), data quality review, trending, Data Management Plan, etc.)

• Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, track study progress, and prepare study status reports.  Anticipates and identifies issues that could affect timelines or quality and develops options and solutions.
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. 
  • Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development, as well as industry trends, data standards, and clinical technologies of importance for data management and contribute to enhancing capabilities and operational efficiencies.
• If assigned, participates as the CDSO study owner in regulatory inspections and internal quality audits
• Conducts study execution “lessons learned”
• Participates in oversight of vendors and provides feedback related to clinical trial operations, issues, and trends in performance
• Responsible for coaching and mentoring team members, which may include indirect supervision of employee as well as supervising the work of contract resources
• Leads DSS innovation and process improvement initiatives and participates in cross-functional initiatives

Must Have for PL I:

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred. PMP Certification or Lean Six Sigma Green Belt desired
• Must have at 3+ years of pharma / clinical research / data management / health care experience or 5+ years of project management experience (and / or applicable work experience)
• Strong understanding of clinical trial process and clinical technology. Experience in managing a clinical trial from initiation through to completion is preferred
• Demonstrated effective leadership skills
• Demonstrated ability to influence others without direct authority
• Demonstrated effective communication skills
• Demonstrated effective analytical skills

Must Have for PL II:

• Bachelor’s degree degree in business, management information systems, computer science, life sciences or equivalent. 
• 6+ years of data management / pharma or biotech / clinical research / health care experience
• In-depth understanding of clinical trial processes and clinical technologies (e.g. EDC, IRT, eCOA), preferably RAVE
• Working knowledge of electronic document management systems
• Management of a clinical trial from initiation through to completion in a data management lead role
• Understanding of ICH and GCP guidelines
• Demonstrated performance as a functional leader
• Demonstrated ability to influence others without direct authority
• Demonstrated ability to successfully coach / mentor
• Demonstrated effective communication skills
• Demonstrated effective analytical skills

Nice to have:

• Master’s degree
• PMP Certification or Lean Six Sigma Green Belt
• Understanding of relevant regulatory requirements and CDISC Standards