Project Manager Clinical
Abbott Laboratories - Des Plaines, IL

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Description:

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.
  • The clinical project manager (CPM) designs, implements, and monitors clinical studies of new and modified in vitro diagnostic products.
  • Ensures that the clinical studies are designed to validate product performance claims and support the products’ intended use.
  • Prepares clinical data reviews and data summaries.
  • Participates in the preparation of regulatory submissions and international registration packages.
  • Manages large projects, more complex projects, and/or several smaller related projects.
  • The CPM has established a high degree of competence in clinical research.
  • The CPM is experienced in all aspects of a clinical research program and functions independently with a significant degree of autonomy in conducting clinical research.
  • The CPM mentors direct reports, provides career development, and conducts performance evaluations.
Qualifications:
  • Knowledge of regulations and standards affecting IVDs and Biologics.
  • Clinical Research 3 to 5 years and Laboratory (hospital, research, industrial)3 to 5 years or Quality Assurance/Auditing 1 to 2 years or Customer Contact 1 to 2 years and Supervisory or management experience 2 to 4 years. Total combined minimum experience = 8 years
  • This position requires previous experience managing larger or more complex clinical studies; the ability to achieve goals through interaction with individuals not under their direct control.
  • Excellent oral and written communication skills.
  • Familiarity with desktop computer office software.
  • Ability to travel (US and/or international), and participation in professional activities outside of normal business hours.
  • Experience with regulations and compliance.
  • Knowledge of regulations and standards affecting IVDs and Biologics.
  • Excellent ability to communicate clearly and accurately to a range of audiences, particularly to study investigators and regulatory agencies, both verbally and in writing
  • Excellent writing and editing skills, including experience writing clinical trial study protocols and reports
  • High level of performance in problem solving, and decision-making and team building skills
  • Proficiency in MS Project and Office including Word, Excel and PowerPoint
  • Experience in working with database systems.
  • Experience interacting with regulatory agencies.
  • Superior project, organization and time management skills
  • Strong interpersonal and communication skills
  • Experience managing project staff and CRAs
  • Experience giving presentations to diverse audiences (internal and external)
  • Bachelor of Science Degree required. Master's preferred.
Significant Work Activities and Conditions:

Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)

Primary Location: USA-Illinois-Des Plaines

Schedule: Full-time

Travel: Yes, 20 % of the Time

CenterWatch - 19 months ago - save job - block
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