Manager Clinical Site Operations, Site ICRA

Abbott • Maple Grove, MN

2d • $99,300 - $198,700 • Onsite

About The Position

The Manager Clinical Site Operations, Site ICRA is an on-site, full-time role located in Maple Grove, Minnesota; Plano, Texas; or Sylmar, California. The position supervises a team of In-house Clinical Research Associates supporting the United States, Canada, and LATAM. It is accountable for functional oversight within Clinical Site Operations and supports hiring, training, development, and retention of qualified staff.

The role supports clinical trials throughout their lifecycle—from start-up through conduct and closure—working independently with minimal guidance while ensuring compliance with study protocols, domestic and international Good Clinical Practices, applicable regulatory standards, and Abbott Standard Operating Procedures. The manager oversees core site deliverables, supports audits and site compliance, collaborates across Site Management and Operations and GCO, and leads small projects and process improvements. The role may require up to 20% travel.

Requirements

• Two-year degree or equivalent experience.
• At least 5 years of people-management experience.
• Experience in clinical research and/or the specific functions overseen by the manager.
• Strong written and verbal communication, interpersonal, presentation, analytical, and organizational skills.
• Ability to interpret basic clinical data, meet deadlines, and communicate effectively with employees at all levels.
• Proficiency in Microsoft Office Suite and relevant clinical applications.
• Ability to work independently when necessary.
• Ability to exchange straightforward information, ask questions, and check for understanding.
• Ability to learn new systems for Trial Master File management and regulatory submissions.

Nice To Haves

• Four-year college degree.
• Five or more years of clinical research experience and two or more years of people-management experience and/or experience in the specific function overseen.
• Excellent understanding of clinical research and strong familiarity with clinical trial research processes.
• Previous related research experience in a clinical or corporate setting, or relevant clinical experience in a clinical or hospital environment.
• Research Professional certification from SoCRA, ACRP, or a similar professional society, as appropriate for regional assignment.
• Organized work habits, ability to coordinate many tasks, accuracy, and attention to detail.
• Regulatory audit experience, such as back-room support.

Responsibilities

• Oversee a team of In-house Clinical Research Associates and ensure assigned clinical studies meet defined core deliverables in partnership with Site and Project Management.
• Oversee site invitation and activation, including checklists and appropriate tracker and CTMS updates.
• Oversee site maintenance activities, including site amendments and re-activation, periodic progress report distribution, and resolution support.
• Ensure regulatory and clinical protocol compliance for assigned clinical projects within functional responsibility.
• Ensure site-level Trial Master File completion and an appropriate level of site audit readiness.
• Prepare for and support site audits and study site compliance escalation activities.
• Oversee site closure and final report distribution.
• Hire, train, manage, develop, and retain qualified staff, potentially working with staffing service providers.
• Support team members' career and personal development and maintain talent profiles, goals, and objectives planning.
• Collaborate with Site Management and Operations and GCO colleagues to achieve regional and national goals and objectives.
• Provide process training and support to internal and external clinical personnel as needed.
• Communicate and collaborate with employees at all levels, customers, contractors, and vendors.
• Apply clinical research process expertise and regulatory knowledge to departmental objectives and improve processes and efficiencies.
• Lead small projects and process-improvement efforts supporting departmental goals.
• Plan, organize, and perform work; monitor performance and report status as necessary.
• Provide input to departmental Standard Operating Procedures and Departmental Work Instructions.
• Serve as a Business Unit Champion for at least one business unit, acting as the Site ICRA team's main point of contact and helping drive activation, review timelines and risks, and resolve issues.
• Maintain knowledge of current clinical regulations and common industry practices; participate in relevant professional associations or societies and pursue continuing education about Abbott devices and therapies.
• Support ad-hoc projects, process-improvement efforts, and Core Team activities as assigned.

Benefits

• Career development opportunities with an international company.
• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, an affordable and convenient path to a bachelor's degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Associate degree