Clinical Program Manager
Franklin Lakes, NJ, USA | BD
Job Description:53 people have viewed this job
The CPgM functions in a critical functional team leadership role, assuming the direct responsibility and accountability for direct management of specific projects, and accountability for delivery of all projects under the assigned program. Typical candidates present with at least 7 years research experience, with SME-level KB in one or more analytic, diagnostic, interventional or therapeutic areas, demonstrable PMD proficiencies, and capability to apply mature IS to deliver results in a matrix / influencing organizational structure. CPgMs are expected to work independently, proactively assess, mitigate and manage risk across all areas of the project, and escalate issues appropriately through the organization. Program or Platform assignment(s) are of high to critical scope & complexity, with an emphasis on delivery of time sensitive studies in a stepwise, parallel path or hybrid approach. CPgMs are expected to drive continuous improvement at multiple project teams and department level. CPMs proactively look to leverage best practices, operate with agility and flexibility, and are expected to develop and implement appropriate risk-based approaches with the appropriate consultation / informing of leadership.
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 Molecular and Point of Care (POC) diagnostics.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, 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 (e.g., 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).
Clinical Study planning and execution for a platform of In Vitro Diagnostic (IVD), sample collection device clinical studies for Molecular and Point of Care (POC) Diagnostics
Excellent communication skills are required, including fluency in verbal and written English; fluency in additional languages is a plus
Demonstrable Project Management skills PMP or PMI-ACP Certification is a preferred goal for all Clinical Program Managers.
Excellent interpersonal communication skills, fluency in additional languages is a plus.
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