Manager, Clinical Operations

4 weeks ago

South Portland, United States Abbott Laboratories Full time

Working at Abbott

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. Youâll 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 bachelorâs 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 Manager, Clinical Operations is within our Infectious Disease business located in South Portland, Maine.  In this role, the Manager, Clinical Operations will oversee the design, implementation, and monitoring of global clinical studies of new and modified in vitro diagnostic products and ensure that the clinical studies are designed to support product performance claims, validate the productsâ intended use, and meet regulatory requirements. This includes project planning, budget, resource management and contract research organization management (as applicable) to ensure that global clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines and company goals. 

What Youâll Work On

  • Lead Global Clinical Operations team of 5+ reports.

  • Define objectives, staff responsibilities, team and personal goals to ensure goal achievement.  Define and monitor performance standards, coaching and mentoring as appropriate.  Motivate staff by appropriate reward and recognition of major achievements. Responsible for mentoring direct reports and their career development.

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

  • Drive the successful and timely completion of clinical research studies to meet regulatory submissions and product market entry dates.

  • Supervise others in the completion of clinical research related tasks and projects.

  • Provide comprehensive management of CROs and other vendors affiliated with the project.

  • Develop and manage global study-level and site-level budgets and provide updates to leadership.

  • Accountable for achievement of both financial and performance goals for projects and overall area of responsibility.

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

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

  • Anticipate future directions and participates in conflict resolution at the management team level and recommend actions and develops responses to cope with changing scenarios.

  • Maintain professional, product, and market expertise via independent reading, networking, and training.

  • Serve as a consultant in broad area of expertise, implements all policies, established procedures, and regulations into daily operations as appropriate.

  • Interview job candidates and hire permanent and contract staff.

  • Manage the orientation and ongoing training of staff.

  • Identify and implement improvements for increased departmental efficiency.

  • Liaison with KOL professionals to develop and execute alignment with Commercial Organization.

  • Attend and provide input into Scientific Advisory Board Meetings.

  • Must comply with and enforce all Office of Ethics and Compliance guidelines.

Requirements

  • B.S. in biological science or medical specialty

  • Minimum 7 years direct clinical research experience and 5 years industry experience of which 3 years functioning in a lead capacity with mentoring, supervisory or demonstrated leadership role

  • Knowledge of regulations and standards affecting IVDs and Biologics

Preferred Qualifications

  • Masterâs Degree desirable

  • Previous Management Experience of over 2+ years in a similar role.

  • Global experience, specifically in developed markets regions

  • Clinical Laboratory Certification MT(ASCP) or CRA (CCRA) 

  • Experience with budgetary responsibility

  • Prior experience managing in a matrix environment

  • Prior IVDR/IVD experience/Clear understanding of relationship of diagnostic test results to patient clinical diagnosis/treatment.

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

* 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 $95,000.00 â $190,000.00. In specific locations, the pay range may vary from the range posted.

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