Clinical Study Manager

3 days left

Recruiter
Location
Waltham MA US
Posted
Aug 23, 2017
Closes
Oct 27, 2017
Organization Type
Clinical Practice
Hours
Full Time
PerkinElmer is a global company focused on improving the health and safety of people and the environment. The Clinical Study Manager will support our Diagnostics Business which provides In Vitro Diagnostic (IVD) products in the prenatal, neonatal and molecular diagnostic markets.

This position is ideal for a senior level clinical professional with experience in the execution of in vitro diagnostic studies in North America. The clinical responsibilities include the oversight and execution of product registration studies, feasibility studies, post-launch studies and collaboration with medical facilities and clinical research organizations to support sample acquisition in support of R&D and service laboratory activities.

Key Responsibilities:
  • Responsible for North America clinical projects for device and service laboratories.
  • Responsible for protocol development and/or review to assure compliance with regulatory requirements and alignment with study objectives.
  • Responsible for clinical trial conduct at multiple external sites.
  • Responsible for coordinating with medical facilities and clinical research organizations to support sample acquisition activities for R&D and service laboratory projects.
  • Primary interface in North America for clinical sites and cross-functional project teams ensuring study execution is on-time and within budget.
  • Initiate, coordinate, and take responsibility for developing supporting documents (such as informed consent, case report forms, etc) related to study conduct, including source documentation, monitoring and study guidelines, and training materials to assure compliance with regulatory requirements and alignment with study objectives.
  • Conduct remote data monitoring and on-site monitoring visits (training, monitoring, close-out) in accordance with Federal regulations (FDA & Health Canada), Good Clinical Practices, ICH guidelines and standard operating procedures.
  • Establish professional rapport and frequent communication with investigational site personnel.
  • Responsible for generation of study reports.
  • Monitor changes in FDA and Health Canada regulations and implement into internal standard operating procedures.