Clinical Data Strategy and Operations Program Lead I - Oncology at AbbVie · LumiJobs

Responsibilities

Aligns CDSO study teams with program- and study-level strategies. For assigned studies, leads the CDSO Study Team and represents CDSO as a member of the cross-functional study team
For assigned studies, acts as single point of contact and accountable operational lead from CDSO. Coordinates associated CDSO study teams to meet operational objectives. Engages and connects global functional and cross-functional teams
Interacts with and influences cross-functional team members to achieve program and study 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. 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
Participates in oversight of vendors and provides feedback related to study operations, issues, and trends in performance
Responsible for coaching and mentoring Data Science Associates. May include indirect supervision of work for contract resources
Participates in CDSO and cross-functional innovation and process improvement initiatives
Contributes to study execution “lessons learned” across functions
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

Clinical Data Strategy and Operations Program Lead I - Oncology

Responsibilities

Qualification

Required

Preferred

Benefits

Company

AbbVie

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