Manager Clinical Site Operations, Site ICRA

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 At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• 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 improvement efforts that are critical to help support departmental goals and objectives. - May participate in Core Team activities and make additional contributions as assigned. - This position might require up to 20% travel. Equipment: Uses standard office equipment, including (but not limited to) personal computer, telephone, FAX, and copier. Working Conditions: Normally works in a cubicle situated in open landscape office environment. Air conditioned. Well lighted. Moderate noise level. Physical Demands: Describe the physical demands representative of those that must be met by an employee to successfully perform the essential functions of this job. Primarily sitting. Some walking. Light effort related to moving, lifting and using office supplies and standard office items. Performs tasks which regularly require good correctable vision and hand/eye coordination. Required

• Two-year degree or equivalent experience, with at least 5 years people management. Experience with clinical research and/or specific functions that the manager is overseeing.
• Must have strong written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to interpret basic clinical data, to meet deadlines as well as the ability to communicate effectively with all levels of employees.
• Must be proficient in Microsoft Office Suite and relevant clinical applications.
• Ability to work independently when necessary.
• Capable of exchanging straightforward information, ask questions, and check for understanding.
• Capable of learning new systems as required for trial master file management and regulatory submissions.

• Preferred 4-year college degree and 5 or more years of clinical research experience, 2 or more years of people management, and/or the specific function that the manager is overseeing.

• An excellent understanding of all aspects of clinical research. A strong familiarity with clinical trials research processes. Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment.
• Certification as a Research Professional by Society of Clinical Research Associates (SoCRA), Association of Clinical Research Professionals (ACRP) or similar profession society as appropriate for regional assignment.
• Work habits include organization, coordination of many tasks, accuracy, and attention to detail.
• Regulatory audit experience (e.g. back-room support).
• ADA Factors (Physical and Environment Demands).
• For each category, check the box that most closely defines the activity required for this position. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an , committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. The base pay for this position is $99,300.00 – $198,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Research and Discovery DIVISION: MD Medical Devices LOCATION: United States > Maple Grove : 6820 Wedgwood Road N. ADDITIONAL LOCATIONS: United States > Sylmar : 15900 Valley View Court WORK SHIFT: Standard

Yes, 20 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf