Manager, Clinical Data Review – Medical Devices (on-site)

Abbott-posted about 2 months ago
$97,300 - $194,700/Yr
Full-time • Manager
Los Angeles, CA
5,001-10,000 employees
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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. We are looking for our next Manager, Clinical Data Review to lead our team on-site out of our Maple Grove, MN or Sylmar, CA location. As a manager, the individual has primary management responsibility directly or through subordinates for all data related to clinical studies. This new team member will have accountability for all data entry activities, Case Report Form (CRF) design, edit check specifications, and other requirements of the Clinical databases, providing datasets and performing data cleaning for analysis. Additionally, will identify and routinely use the most effective, cost efficient and best business practice to execute processes; continually evaluate their effectiveness and appropriateness. The Manager, Clinical Data Review will exercise judgment in planning, organizing and performing work; monitor performance and report statuses to executive management as well as assures that quality of services meets internal and external customer requirements.

  • Responsible for hiring and retaining a diverse, highly qualified data management staff and for providing career coaching, growth, and personal development.
  • Accountable for staff development: critiques, instructs, mentors, evaluates, and coaches.
  • Ensures staff is appropriately trained in processes and procedures; ensures established processes and procedures are being followed and documented.
  • Accountable for the performance of subordinates and work output of managed subcontractors.
  • Maintains a safe work environment and a strong customer focus.
  • Models optimum leadership competencies to inspire an energized, empowered and accountable work force.
  • Manages data entry, data cleaning, data deliverables, and other data management activities.
  • Oversees the development of CRFs, edit check specifications, and additional data collection requirements required for tracking and analysis.
  • Manages processes to ensure data integrity via appropriate data management processes.
  • Manages custom requests and reporting from clinical databases made by the Clinical department and other departments.
  • Provides other departments with outputs from clinical databases as necessary.
  • Remains current on developments in field(s) of expertise, regulatory requirements, and industry trends.
  • Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.
  • Sets goals which align to department plans and manages the execution of goals through coaching and mentoring.
  • Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Bachelor's degree in a science-related field or an equivalent combination of education and experience.
  • Minimum 8 years’ progressively more responsible experience in the pharmaceutical, bio-technology or medical device industry.
  • Advanced computer skills in graphics, word-processing, databases, authoring programs, etc.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback.
  • Ability to work effectively within a team in a fast-paced changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multi-tasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.
  • Experience working in a broader enterprise/cross division business unit model.
  • Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit.
  • Career development with an international company.
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