Strategic CDSO Lead - Clinical Data Ops & Programs

AbbVie; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Paid time off

401(k) plan

Short-term incentives

Job summary

AbbVie Data Science 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 emphasizes execution and innovation, with the role serving as a key to ensuring delivery against CDSO accountabilities and cross-functional programs.

This position requires strong leadership across functional teams, deep understanding of clinical trial processes, and

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.

Responsibilities

• Aligns CDSO study teams with program- and study-level strategies.
• Acts as single point of contact and accountable operational lead from CDSO.
• Coordinates CDSO 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, 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.
• Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and to functional quality standards.
• Stays abreast of new and 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 CDSO 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.
• May include direct and/or indirect supervision of staff, as well as contract resources.

Skills

Cross-functional leadership

Communication skills

Analytical skills

Mentoring

Education

Bachelor's degree

Master's degree preferred

Job description

AbbVie Data Science 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 emphasizes execution and innovation, with the role serving as a key to ensuring delivery against CDSO accountabilities and cross-functional programs.

This position requires strong leadership across functional teams, deep understanding of clinical trial processes, and