Associate Director - Global Study Start Up Transformation Lead
AbbVie
3 months ago
Remote friendly (North Chicago, IL)
United States
Clinical Research and Development
Responsibilities:
- Transformation Planning & Execution: Assist in developing and executing a comprehensive training plan (timelines, milestones, deliverables) to transform SSU processes; drive best-practice sharing/lessons learned and continuous improvement using Key Risk and Performance Indicators, metrics, and benchmarking.
- Stakeholder Management: Collaborate with internal/external stakeholders; maintain communication lines to support Director in managing relationships.
- Vendor Selection: Participate in vendor selection; evaluate capabilities/experience/fit; support procurement and legal teams in contract negotiations and service level agreements.
- Project Coordination: Support Director to ensure transformation adheres to timelines, budgets, and quality standards; identify and mitigate risks/issues.
- Process Documentation: Document current SSU processes/workflows/SOPs; identify improvement areas and recommend changes.
- Change and Risk Management: Develop and implement change management and risk strategies; provide training/support for SSU operational roles.
- Performance Monitoring: Assist in establishing KPIs/metrics for offshoring hub(s); monitor vs. targets and take corrective actions.
- Automation Development: Improve efficiency/quality via AI/automation; coordinate implementation of automation initiatives.
- Relationship Management: Partner cross-functionally; support hub(s) and internal teams as a secondary contact for SSU issues/escalations; attend meetings/performance reviews.
- Continuous Improvement: Optimize SSU processes; identify cost savings, automation opportunities, and innovation.
- Team Leadership: Assist in leading a team to develop activity-level SOPs and transition documents.
Qualifications:
Required:
- Bachelor’s degree in a healthcare or scientific field.
- 7+ years clinical project management and global study start-up experience.
- 4+ years line management experience (talent acquisition, performance management, employee relations, coaching, mentoring).
- Proven cross-functional global leadership; ability to influence and align stakeholders.
- Strong analytical/critical thinking.
- Excellent interpersonal skills; persuasive, clear communication.
- Demonstrated program execution (preferably in start-up) and ability to manage multiple priorities.
- Expertise in drug development, operations, and global resource/budget planning.
- Vendor management experience (identification/selection/performance oversight and collaborative relationships).
- Advanced knowledge of ICH and GCP and operational understanding of the global regulatory environment.
Preferred:
- Demonstrated success developing and retaining high-potential/high-performing staff.
Benefits (as stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k).
- Eligible for short-term and long-term incentive programs.
- Transformation Planning & Execution: Assist in developing and executing a comprehensive training plan (timelines, milestones, deliverables) to transform SSU processes; drive best-practice sharing/lessons learned and continuous improvement using Key Risk and Performance Indicators, metrics, and benchmarking.
- Stakeholder Management: Collaborate with internal/external stakeholders; maintain communication lines to support Director in managing relationships.
- Vendor Selection: Participate in vendor selection; evaluate capabilities/experience/fit; support procurement and legal teams in contract negotiations and service level agreements.
- Project Coordination: Support Director to ensure transformation adheres to timelines, budgets, and quality standards; identify and mitigate risks/issues.
- Process Documentation: Document current SSU processes/workflows/SOPs; identify improvement areas and recommend changes.
- Change and Risk Management: Develop and implement change management and risk strategies; provide training/support for SSU operational roles.
- Performance Monitoring: Assist in establishing KPIs/metrics for offshoring hub(s); monitor vs. targets and take corrective actions.
- Automation Development: Improve efficiency/quality via AI/automation; coordinate implementation of automation initiatives.
- Relationship Management: Partner cross-functionally; support hub(s) and internal teams as a secondary contact for SSU issues/escalations; attend meetings/performance reviews.
- Continuous Improvement: Optimize SSU processes; identify cost savings, automation opportunities, and innovation.
- Team Leadership: Assist in leading a team to develop activity-level SOPs and transition documents.
Qualifications:
Required:
- Bachelor’s degree in a healthcare or scientific field.
- 7+ years clinical project management and global study start-up experience.
- 4+ years line management experience (talent acquisition, performance management, employee relations, coaching, mentoring).
- Proven cross-functional global leadership; ability to influence and align stakeholders.
- Strong analytical/critical thinking.
- Excellent interpersonal skills; persuasive, clear communication.
- Demonstrated program execution (preferably in start-up) and ability to manage multiple priorities.
- Expertise in drug development, operations, and global resource/budget planning.
- Vendor management experience (identification/selection/performance oversight and collaborative relationships).
- Advanced knowledge of ICH and GCP and operational understanding of the global regulatory environment.
Preferred:
- Demonstrated success developing and retaining high-potential/high-performing staff.
Benefits (as stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k).
- Eligible for short-term and long-term incentive programs.