Principal Clinical Strategy Manager

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 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

Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

The Principal Clinical Strategy Manager is responsible for managing and meeting the objectives of clinical projects including but not limited to New Technology Assessments (NTA).  This role is based out of our Lake Forest, IL office. The person hired in this role will interface internally with Clinical Operations, Clinical systems, data management, biostatistics, regulatory, clinical research associates, field clinical specialists, functional management, cross-functional team members and business alliance leads (sales and marketing). They will also work with business units, both in the United States and OUS. There will be up to 25% of travel in the US and outside of the USA required in this role. In addition, the role is in the office 5 days a week on the other days you are not travelling.

What You’ll Work On

• Determine 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.

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

• Ensure 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.).

• Enlist support and determine which tasks are required for various team members to assure meeting objectives are completed on schedule.

• Provide 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.

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

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

• Controls logistics, distribution and allocation of various materials.

• Monitor project reports for accuracy and trending. Provide input to project budgets and project plans.

• Provide clinical, medical and scientific support to project teams.

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

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

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

• Communicate with and provides updates to specific core teams.

• Oversee activities delegated by Sr. Clinical strategy Manager or Director, Clinical Affairs.

• Provide 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 requirementsEstablish project priorities and allocate resources and workload to support business priorities.

Qualifications:

Required

• Bachelors Degree in related life science field

• Minimum of 8-10 years directly supporting clinical research or similar experience in a medical/scientific area 3-4 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).

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

• Able to travel as needed (<25%).

Preferred

• Master's Degree or PhD strongly preferred in similar area.

• Previous experience in Clinical Microbiology or Infectious diseases.

• Human Clinical Trials Project Management Experience.

Competencies:

• High attention to detail and accuracy.

• Advanced written and oral communications skills.

• Strong problem-solving skills.

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* 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 $90,700.00 – $181,300.00. In specific locations, the pay range may vary from the range posted.

• clinical operations
• clinical strategy
• clinical data
• clinical management
• clinical research
• clinical systems
• outcomes research
• divisional management
• data management
• project management experience
• managing projects
• meeting objectives
• medical terminology
• summary reports
• functional management
• regulatory compliance
• publications
• gcps
• logistics
• fda
• human clinical trials project management
• quality management systems
• product development
• ems
• alliance

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