Manager Clinical Site Operations, Site ICRA

Abbott (abbottcareers2 board); Maple Grove (MN); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

Tuition reimbursement

Excellent retirement plan

Career development

Job summary

Abbott is seeking an Assistant Manager, Clinical Site Operations for an on-site, full-time role. The position may be located in Maple Grove, MN, Plano, TX, or Sylmar, CA, overseeing a team supporting US, Canada, and LATAM.

You will hire, train, and retain qualified CSO staff, ensuring adherence to study protocols, GCP, and Abbott SOPs. You will lead functional oversight of In-house CRAs, drive activation, and manage timelines, risks, and issue resolution while collaborating with Site Management

Qualifications

• Experience in clinical operations and regulatory knowledge.
• Ability to lead and develop staff.
• Familiarity with GCP and regulatory standards.
• Strong problem-solving skills.

Responsibilities

• Ensure team achieves goals for core deliverables in clinical studies (in partnership with Site and Project Management).
• Lead site activation, maintenance, and related CTMS updates.
• Ensure regulatory and protocol compliance across projects and site audits.
• Oversee hiring, training, and staff development within CSO.
• Collaborate with Site Management, Operations and GCO to achieve goals.
• Drive process improvements and contribute to SOPs.

Skills

Team leadership

Hiring & training

Regulatory compliance

Clinical operations

Tools

CTMS

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position is an on-site full-time role and can be located at our Maple Grove, MN or Plano, TX or Sylmar, CA locations.

This position is responsible for the supervision of a team of personnel within Clinical Site Operations (CSO) which supports US, Canada, and LATAM. Assists management in hiring, training, developing, and retaining qualified staff for CSO. In addition, this position supports work during the lifetime of Abbott clinical trials including start-up, conduct and closure working independently with minimal guidance, direction and ensuring compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Abbott Standard Operating Procedures.

Able to solve complex problems; consider alternative or new perspectives using existing tools and standard processes. The Assistant Manager, Clinical Site Operations is accountable for functional oversight within CSO. For this role, they will be responsible for a team of In-house Clinical Research Associates.

What You’ll Work On

• Responsible and accountable for ensuring the team reaches defined goals for core deliverables of assigned clinical studies (in partnership with Site and Project Management) such as but not limited to:
• Site Invitation.
• Site Activation (incl. checklist and appropriate tracker- and CTMS updates).
• Site Maintenance activities such as but not limited to:
• Site Amendment/Re-activation (incl. checklist and appropriate tracker- and CTMS updates)
• Periodic Progress Report distribution and resolution support
• Ensuring both regulatory and clinical protocol compliance is maintained for all assigned clinical projects as appropriate for functional responsibility.
• Trial Master File completion at site level and ensuring an appropriate level of Site Audit Readiness.
• Site Audit preparation and support.
• Study Site Compliance Escalation activities.
• Site Closure and Final Report distribution.
• Responsible for hiring, training, managing, developing, and retaining qualified staff. This may include engagement with service providers that provide staffing contractor services.
• Supports career and personal development of team members as well as creation and maintenance of talent profile, goals, and objectives planning.
• Partners and collaborates with colleagues within Site Management and Operations and GCO to achieve regional and national goals and objectives.
• Provides support and training to internal and external clinical personnel on functional processes, as needed.
• Communicates and collaborates with all levels of employees, customers, contractors, and vendors.
• Applies expertise in clinical research processes and regulatory knowledge to the clinical department goals and objectives and actively improves processes and efficiencies.
• Leads small projects and process improvement efforts that are critical to help support departmental goals and objectives.
• Exercises judgment in planning, organizing, and performing work, monitors performance and reports status as necessary .
• Provides input to departmental Standard Operating Procedures (SOPs) and Departmental Work Instruction (DWIs).
• Serves as a Business Unit Champion to at least one BU to support study execution as the main point of contact for the Site ICRA team, drive activation, review of timelines, risk, and finds solutions to drive success.

Other Duties

• Has strong knowledge of current clinical regulations and common industry practices.
• Engages in relevant professional associations or societies and seeks continuing education about Abbott devices and therapies.
• May support ad-hoc projects and process improveme