Clinical Project Manager

Posted November 30, 2011
Business MED Institute, Inc.
Purdue Research Park of West Lafayette,
n/a
Position Type Full Time
Start Date Immediate Availability

Duties / Responsibilities

  • Develop and maintain a working knowledge of FDA and other regulatory requirements that may impact global clinical studies including ICH GCP, JGCP and ISO 14155
  • Provide leadership in the development and review of study-related documents
  • Establish and maintain close working relationships with physicians, outside consultants and the study sponsor through exceptional communication on a regular basis
  • Provide review of invoices from study vendors, IRB approvals and informed consent documents, monitoring reports, etc.
  • Provide leadership in scheduled study team meetings with both internal and external resources
  • Train the clinical project team, including investigators and site research staff, on the study protocol and use of the device
  • Work closely with the Clinical Process Management and Clinical Science teams to develop and implement specific study plans and ensure that appropriate resources are available for the project
  • Participate in and conduct visits and meetings with investigative sites, physicians and consultants
  • Responsible for achieving study objectives by working with clinical project team members to set project priorities and milestones and resolve project conflicts
  • Track study metrics (progress) in order to manage investigative site and study team resources toward achievement of milestones; ensure Clinical Process Management and Clinical Science teams are appropriately informed in a timely manner to offer guidance in resolving the issues
  • Respond promptly and appropriately to study issues raised by investigative sites, sponsors, monitors and consultants
  • Participate in the analysis, summarization and reporting of clinical data for regulatory or marketing purpose throughout the course of the study

Requirements / Qualifications

  • A Bachelor’s degree with significant relevant experience is required
  • Masters degree in Health, Life Sciences or Biomedical Engineering, preferred
  • Previous experience in the conduct of clinical studies preferred, preferably in the medical device industry
  • Proven ability to exercise sound judgment in independent decision making
  • Conscientious, influential person with an outstanding work ethic and strong personal discipline
  • Ability to interact with physicians, scientists and company executives in a professional and personable demeanor in a variety of settings and interactions
  • Willingness and capability to handle multiple projects and responsibilities
  • Excellent organizational, leadership and problem-solving skills
  • Excellent written and verbal communication skills
  • Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues
  • Experience in writing technical documents
  • Willingness and ability to travel 25-50% of the time

Company Description

MED Institute, Inc. was established as a resource for Cook Group companies to identify and develop new medical product concepts. This includes new product discovery, prototype development, nonclinical testing, clinical study management and data analysis, education for the medical community, and preparation of regulatory submissions. MED Institute employs a staff of research, medical, engineering, and administrative professionals.

Other

Benefits include 401k and profit sharing plans, health, dental, life and optical insurance, eight paid holidays per year, and vacation.

MED Institute is an Equal Opportunity Employer (EOE).

Application Instructions

Please e-mail resume to hr@medinst.com.

We accept Word documents and PDF's.