Clinical Data Strategy & Operations Program Lead II

Summary

Join AbbVie's Data Science team as a leader, aligning study teams with program strategies, acting as a single point of contact for operational matters, and ensuring successful delivery. You will coordinate global teams, utilize project management tools, and maintain adherence to regulations. Responsibilities include coaching team members, leading innovation initiatives, and conducting lessons learned sessions. The ideal candidate possesses a Bachelor's degree (Master's preferred) and significant experience in pharma/clinical research or project management. Remote work is possible. AbbVie offers a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k).

Requirements

• To be successful in this role, you should have a Bachelor’s degree in business, management information systems, computer science, life sciences or an equivalent
• 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience)
• Performance as a functional leader
• Ability to influence others without direct authority
• Ability to successfully coach / mentor in a matrix environment
• Effective communication skills
• Effective analytical skills

Responsibilities

• Aligns DSS study teams with program- and study-level strategies. Assigned programs may include programs that are of low complexity and size. For assigned programs and studies, leads the DSS Study Team and represents DS as a member of the cross-functional study team
• For assigned programs and studies, 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 the study level
• 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. 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. If assigned, 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
• Leads DSS innovation and process improvement initiatives and participates in cross-functional initiatives
• Conducts study execution “lessons learned” across functions
• May include indirect supervision of employee as well as supervision of work of contract resources

Preferred Qualifications

• A Master’s degree is preferred
• PMP Certification or Lean Six Sigma Green Belt desired
• In-depth understanding of clinical trial processes and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is preferred
• While there is a preference to have someone who can work from one of our sites, remote work is possible

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)