Clinical Data Strategy and Operations Program Lead II (Onsite or Remote)

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Requirements:

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent.
• 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience).
• In-depth understanding of clinical trial processes and clinical technology.
• Demonstrated performance as a functional leader.
• Demonstrated ability to influence others without direct authority.
• Demonstrated ability to successfully coach / mentor in a matrix environment.
• Demonstrated effective communication skills.
• Demonstrated effective analytical skills.

Responsibilities:

• Aligns DSS study teams with program- and study-level strategies.
• Acts as single point of contact and accountable operational lead from DSS.
• Interacts with and influences cross-functional team members to achieve program objectives.
• Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports.
• 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.
• 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.
• Leads DSS innovation and process improvement initiatives and participates in cross-functional initiatives.
• Conducts study execution “lessons learned” across functions.