Global Clinical Trial Operations Lead

Abbott; Madison (WI); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott in Madison, WI is seeking a Clinical Trial Manager to support or lead the management, planning, execution, and closure of clinical studies. The CTM collaborates cross-functionally to oversee day-to-day operations and ensure successful execution of Abbott’s clinical research plans.

This role may be based in Madison, WI or San Diego, CA and requires a life sciences degree, 5+ years in clinical research, and strong vendor oversight.

Qualifications

• Bachelor’s degree in life sciences or related field as required for essential duties.
• 5+ years of experience in clinical research.
• 1+ year leading project teams through start-up, conduct, data management, analysis, close-out and report writing of clinical studies.
• Clinical monitoring experience including data review, query resolution, protocol deviation identification/tracking/trending, site initiation, maintenance and closeout visits.
• Experience writing, reviewing and editing protocols.
• Knowledge of Good Clinical Practices (ICH/GCP), ISO 20916 and applicable regulations governing clinical research.
• Authorization to work in the US without sponsorship.
• Ability to perform essential duties with or without accommodation.
• Experience overseeing external vendors (CROs, central labs, call centers, DCT providers).

Responsibilities

• Coordinate and oversee operational aspects of a study including planning, start-up, enrollment and close out activities.
• Prepare, review and implement study plans and documents including timelines, protocols, ICFs, recruitment plans, monitoring plans, budgets, site contracts and budgets, vendor plans.
• Develop systems and materials to support efficient execution of clinical studies and manage during conduct.
• Develop, implement and maintain tools to monitor study health, timelines and finances for management and stakeholders.
• Participate in study database development and CRF design, guideline development, edit checks and UAT.
• Oversee sample management activities including planning, handling, shipping, processing and results.
• Develop site recruitment plans and monitor site performance.
• Forecast and manage study expenses; oversee site contracting and budget management, invoicing, accruals and budget tracking.
• Oversee training, data entry, TMF maintenance and ensure compliance with study plans.
• Conduct monitoring activities as needed.
• Ensure closure of studies through data verification, database lock planning, site readiness and report development.
• Identify, qualify and manage vendors for study support.
• Provide guidance to team members and foster knowledge sharing.
• Lead cross-functional meetings and interact with investigators, sites, vendors and consultants.
• Travel up to 20% as required.

Skills

Clinical trial management

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree in life sciences

Job description

Abbott in Madison, WI is seeking a Clinical Trial Manager to support or lead the management, planning, execution, and closure of clinical studies. The CTM collaborates cross-functionally to oversee day-to-day operations and ensure successful execution of Abbott’s clinical research plans.

This role may be based in Madison, WI or San Diego, CA and requires a life sciences degree, 5+ years in clinical research, and strong vendor oversight.