Clinical Affairs Project Manager

Regulatory Affairs/Clinical Affairs Bronx, New York Minneapolis, Minnesota


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

We are currently searching for an experienced Clinical professional who will be responsible for the execution of multiple Phase I-IV Clinical Trials. The Clinical Trials Manager may be responsible for some or all of the following, depending on the Trial(s) being managed:

  • Protocol/amendment development (including review of all applicable literature such as SBAs, FDA guidance’s, and other publications).
  • CRF design, modification/creation of ICF, Investigator Brochures, presentations and training materials.
  • Study related forms/reports and source documents in collaboration with the CRO and development of submission materials for FDA review and consideration.
  • Clinical trail material sourcing, packaging, labeling, blinding and distribution oversight.

Requirements:

  • A Bachelor's in a Scientific discipline is required.  An Advanced Degree is preferred.
  • A minimum of five to seven (5-7) years of professional experience within Clinical, Regulatory or another Scientific field is required; at least two (2) years of CRA experience is highly desired.
  • Complete understanding and wide application of technical standards, principles, theories, and concepts in the field.
  • Advanced computer proficiency in Word, Excel, PowerPoint and MS Project.
  • Knowledge/mastery of Federal regulations and Clinical guidance’s.
  • Demonstrated advanced skills in decision making, problem solving, and risk mitigation planning.
  • The position requires substantial responsibility for strategic planning, design, implementation and follow-through of decisions/tasks dictated by Project, Project Team and/or Business unit.
  • This position requires about 10-15% travel to investigational sites, other Perrigo locations and Contract Research Organizations (CROs).
  • Experience in dermatology, women’s health, respiratory, Gastro-intestinal, ophthalmology, bio-equivalence trials is preferred, but not required.