Senior Manager, Document Management

Summary

Join AbbVie's CDMSO team as a leader in continuous improvement initiatives. This role involves advising employees, developing high-performing teams, and allocating resources across therapeutic areas. Responsibilities include prioritizing workloads, maintaining inspection readiness, leading departmental initiatives, ensuring GCP and AbbVie SOP compliance, and acting as a Business Process Owner for Document Management. You will contribute to CDMSO strategy, coach team members, analyze metrics, and promote a culture of innovation. This US-based remote position requires strong leadership, communication, and project management skills. The ideal candidate will have a Bachelor's degree (life sciences or business preferred) and significant experience in clinical document management or clinical research, including people management.

Requirements

• Bachelor’s degree or international equivalent is preferred
• With at least 8 years clinical document management or clinical research industry-related including Supervisory/ leadership
• At least 3 years People Management experience
• If no BS, 12 years professional clinical research relevant work experience
• Proven communication, organizational, project management and leadership skills
• Skilled at problem solving and prioritization at operational and tactical levels
• Ability to analyze organizational needs and assist in the design, implementation, and maintenance of flexible work teams, capable of meeting changing business and regulatory requirements
• Ability to lead operational strategy and deliverables for the business
• Ability to lead employees through organizational changes
• Proficient in leading risk/impact assessment and change management within the organization
• Effective, strong leadership competencies with broad business orientation
• Ability to drive strategic and operational goals through project advisement, prioritization and employee development
• Ability to lead employees through organizational, process and procedural changes

Responsibilities

• Implement the vision and process framework of the CDMSO team by advising employees and teams on executing continuous improvement initiatives
• Coordinate highly effective teams by developing staff and delegating appropriate work assignments and priorities to execute continuous improvement initiatives
• Plan and allocate functional resources, develop and manage high-performing teams, and assign tasks across one or more therapeutic areas to achieve objectives while ensuring compliance with GCP and AbbVie SOPs
• Prioritize workloads and maintain real-time inspection readiness of Master Files and plans and allocates resources effectively across assigned therapeutic areas
• Lead departmental and cross-functional initiatives within the broader Development Organization
• Maintain compliance with GCP, AbbVie SOPs, and functional area processes for both staff and clinical documentation in assigned therapeutic areas
• Act as an advisor on clinical documentation initiatives and serve as the Business Process Owner for Document Management
• Contribute to setting CDMSO strategy, goals, and initiatives as part of the CDMSO leadership team
• Coordinate cross-functional initiatives and ad hoc projects
• Coach and mentor team members for professional growth within team and the broader organization
• Analyze metrics, recommend actions, and collaborate with the systems team to identify improvement areas
• Promote a culture of innovation, collaboration, and professional development
• Meet with Program Leads and stakeholders to update on TMF health, escalate issues, and discuss milestone and regulatory filing dates
• Has direct reports

Preferred Qualifications

Degree in life sciences or business preferred

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs