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 114,000colleagues serve people in more than 160 countries.
Clinical Project Manager
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
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, ensure adequate monitoring is conducted on all clinical project
- Conduct clinical visits as needed to support NTA and/ or applicable clinical project.
- Enlists support and specifies tasks for various team members to ensure meeting objectives are completed on schedule.
- 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.
- Provide 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.
- Communicates with and provides updates to specific core teams.
- Oversees activities delegated by Sr. Clinical Research Manager or Sr. Director, Clinical
- 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 in Engineering, biological sciences or related medical/scientific field.
- Masters and/or Doctorate Degree preferred
- Minimum 3 years: 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.
Preferred Qualifications
- High attention to detail and accuracy.
- Advanced written and oral communication skills.
- Ability to manage multiple tasks.
- 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.
- Able to travel as needed (