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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 .

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The position of Senior Manager, Clinical Operations is within the Medical, Clinical & Scientific Organization (MCSO) function of the Rapid Diagnostics Infectious Disease business, based in South Portland, Maine.

In this role, the Senior Manager, Clinical Operations will lead the strategic design, planning, and execution of global in vitro diagnostic (IVD) clinical trials within the Rapid Diagnostics Infectious Disease business unit. This role demands a visionary leader with a proven track record in managing complex trials, driving cross-functional collaboration, and ensuring alignment business objectives and financial targets.

• Lead the strategic execution of complex global clinical IVD trials for the Rapid Diagnostics Infectious Disease business unit.

• Provide oversight and performance management of the Clinical Operations team consisting of 10-15 team permanent staff including Clinical Trial Managers, Clinical Research Associates (CRAs), and Clinical Research Coordinators, in addition to external contract CRAs when needed.

• Define Clinical Operations strategic goals, objectives, staff responsibilities and manage team resourcing to ensure goal achievement.  Develop, report and monitor functional metrics, KPIs, and team performance standards. Identify and implement improvements for increased efficiency.

• Maintain accountability for achievement of both financial and performance goals for clinical trial projects and overall area of responsibility. Develop and manage global study-level and site-level budgets and staff resourcing projections. Ensure clinical trial execution is on time and within budget.

• Provide regular updates and transparent communication at the senior management executive level. Anticipate future directions and participate in conflict; recommend proactive risk mitigation and develop responses to cope with changing scenarios.

• Ensure effective collaboration and coordination across the Clinical department, MCSO, and other departments. Break down silos and promote a cohesive organizational culture.    

• Ensure strict adherence to Good Clinical Practices, Industry standards, standard operating procedures and to all other quality standards in conducting IVD research and development.

• Ensure clinical studies are designed and executed to support product performance claims, validate the products’ intended use and meet global regulatory requirements (e.g. FDA, NMPA, MHRA, etc.)

• Responsible for understanding and application of Global regulatory requirements related to IVD clinical studies and accountable for complying with all relevant requirements.

• Remain current with global regulations and clinical requirements for diagnostic products and translate regulatory requirements into clinical study activities, processes and procedures.

• Effectively communicate, through the planning and execution of meetings and presentations, project goals, milestones, and status updates to senior executive management, other functional areas, and regulatory authorities.

• Provide comprehensive management and oversight of CROs and other vendors affiliated with projects as needed.

Required Qualifications:

• B.S. in biological science or equivalent required, advanced degree desired (Master’s, PhD, etc.)

• Minimum 10 years direct clinical research experience and 3- 5 years functioning in a leadership role in a matrixed environment

• Prior experience managing and executing global clinical trials in a matrixed environment

• Knowledge of global clinical trial regulations and standards affecting IVDs and Biologics.

Preferred Qualifications:

• Master’s or advanced degree desirable

• Prior IVDR/IVD experience and a clear understanding of relationship between diagnostic test results and patient clinical diagnosis/treatment.

• Proven leader with passion and skills for strategic and critical thinking, problem solving, motivating and mentoring team members

• Excellent spoken and written English and local language skills

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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 Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

The base pay for this position is

$125,300.00 – $250,700.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Clinical Affairs / Statistics

     

DIVISION:

ID Infectious Disease

        

LOCATION:

United States > South Portland : 65 Gannett Drive

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 20 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

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 Equal Opportunity Employer 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