Clinical Data Strategy and Operations Program Director
3 days ago
At AbbVie, we're driven by a passion to discover and deliver innovative medicines and solutions that transform lives. As a key member of our Data Science team, you'll play a vital role in bringing people, process, and technology together to generate business value from clinical trials data.
Job Description: This role is a key to ensuring successful delivery against program- and study-level accountabilities assigned to Data and Statistical Sciences. You'll align DSS study teams with program- and study-level strategies, supporting governance of assigned programs and studies, both within and outside DSS.
Responsibilities:
• Aligns DSS study teams with program- and study-level strategies. Supports governance of assigned programs and studies, both within and outside DSS.
• Acts as single point of contact and accountable operational lead from DSS. Coordinates associated DSS study teams to meet operational objectives. Engages and connects global functional and cross-functional teams at both the program and study levels.
• Interacts with and influences all levels of management and cross-functional team members to achieve program objectives. Represents DS in cross-functional forums and, if assigned, leadership meetings.
• Utilizes operational analytics and project management tools to optimize execution of programs and studies. Manages internal and external resources, tracks study progress, and prepares study status reports. Anticipates and identifies issues that could affect timelines of own, as well as studies managed by the team.
• 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. Coordinates and participates as the DS study owner in regulatory inspections and internal quality audits.
• 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, as well as providing input into their development.
• Leads DSS and cross-functional innovation and process improvement initiatives.
• If assigned, responsible for identifying training needs and standardizing and facilitating training solutions for DS roles. Conducts lessons learned across functions.
Qualifications:
• 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 8+ years of pharma / clinical research / data management / health care experience or 10+ years of project management experience (and / or applicable work experience).
• In-depth understanding of clinical trial processes and involved functional stakeholders, and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is required.
• Demonstrated performance as a cross-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.
Estimated Salary: $117,500 - $223,500
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
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