Clinical Program Manager
Franklin Lakes, NJ, USA | BD
Job Description:54 people have viewed this job
Specific to this position, the CPgM leads the consulting, planning, implementation, execution and/or oversight of human subject clinical trials for the purposes of evidence generation supporting MDR/IVDR compliance, or other applicable regulatory requirements, or to meet pre-defined postmarket surveillance requirements, across all Company Business Units.
The CPgM will develop effective and efficient operating relationships with GCD Portfolio Managers and peer Program Managers. Possible projects will be funneled by Portfolio Managers to the CPgM, and early phase assessment, diligence and scenario analysis on scope, timeline and budget.
CPgM will lead, or oversee an assigned CPM’s, delivery of project planning, execution, monitoring / controlling and close out, aligned with BU study design and objectives, including those imposed by Notified Bodies to obtain or renew CE marking.
This position reports directly to the Senior Manager, Clinical Portfolio Management Europe, GCD and collaborates with Medical Affairs and Regulatory Affairs teams in the BUs, as well as BU Portfolio and Project Managers.
A Bachelor’s Degree, or regional equivalent, in the Life or Medical Sciences, typically but not limited to Biology, Biochemistry, Biomedical Engineering, Chemistry, Microbiology, Immunology, Physiology, Toxicology and Zoology.Graduate and/or Postdoctoral degrees are preferred.The degree is a requirement unless an equivalent combination of education, experience and certification / licensure from an appropriately credited organization is sufficient for an associate to work reasonably independent of supervision.
A minimum of 7-years’ experience in human subject research.
Responsible for managing the design, development, modification, and evaluation of all clinical development plans (eg budget, timelines, gaps analysis, etc) as well as the implementation of those plans
Manage applicable staff and program(s) / project(s) within a Business Unit area, whether direct or indirect
Extensive knowledge of regulatory aspects concerning human subject research (e.g.ICH-E6 GCP and ISO 14155, as well as MDD and MDR);
Excellent communication skills are required, including fluency in verbal and written English; fluency in additional languages is a plus
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