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Abbott Clinical Project Manager in Alameda, California

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.

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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. 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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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.

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

The Opportunity

The Clinical Manager is responsible for managing and meeting the objectives of clinical projects including but not limited to New Technology Assessments (NTA). Internally interfaces with data management, biostatistics, regulatory, clinical research associates, trial coordinators, field clinical specialists, functional management, cross-functional team members and business alliance leads (sales and marketing).

What You'll Work On

  • Determines NTA or applicable project objectives, strategy, scope and schedule to meet business needs. Develops the NTA or applicable project Plan in consultation with the cross-functional project team, project stakeholders and the clinical team. Presents project plans, provides ongoing updates, and presents project results to Division senior clinical management.

  • Assists in the management and execution of the NTA and/ or applicable clinical project.

  • Ensures all Division staff are trained on the requirements of the clinical project and project plan.

  • Responsible for ensuring the clinical project is “audit ready” at all times (project team training records, central files, system validation, etc.).

  • If applicable, ensures adequate monitoring is conducted on all clinical project, conduct clinical visits as needed to support NTA and/ or applicable clinical project.

  • Provides oversight of NTA and clinical projects to ensure safety concerns and/or adverse events or trends in Field Events Reporting are identified and appropriate responses are developed and executed.

  • Provides clinical input and support for planning post-project activities and product market launch.

  • If applicable, authors/co-authors project results in medical literature plans and/or presents at scientific investigation meetings.

  • Controls device distribution and allocation.

  • Monitors project reports for accuracy and trending, provides input to project budgets and project plans and clinical scientific support to project teams.

  • Evaluates clinical data in preparation of study summary reports for presentations, publications, and submissions.

  • Develops and implements corrective actions as needed to address any noncompliance issues.

  • Performs LA Reviews of marketing materials related to NTA or applicable clinical project.

  • Provides input and support for planning post-trial clinical activities and product market launch.

  • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Required Qualifications

  • Bachelors Degree Engineering, biological sciences or related medical/scientific field. Preferred Masters Degree or Doctorate Degree.

  • Minimum 3 years experience directly supporting clinical research or similar experience in a medical/scientific area, plus 1-3 years experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting.

  • Proficient knowledge of medical terminology. Expertise with GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA). Strong problem-solving skills.

  • Advanced knowledge of clinical and outcomes research study design. Strong computer skills. Demonstrated ability to work effectively on cross-functional teams.

  • Experience with software related testing and validation are preferred.

Apply Now (https://www.jobs.abbott/us/en)

  • 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 $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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