Purdue Research Park Network - Career Postings

Back

Clinical Project Manager
MED Institute, Inc.
West Lafayette

Date:  8/9/2010
Position Type:  Full Time

Start Date:  Immediate Availability

Duties/Responsibilities:

Summary:

This management-level position is responsible for working closely with the Director of Clinical Trials to coordinate global clinical studies on behalf of the Cook organization. 

• Provide leadership in the development of study-related documents, including study protocols, informed consent documents, investigator files, DSMB handouts and presentations, CEC summaries, etc.
• Establish close working relationships with physicians, their research staff, outside consultants and the study sponsor through exceptional communication on a regular basis.
• Provide review and approval of invoices from study vendors, IRB approvals and informed consent documents, monitoring reports, clinical study agreements, etc.
• Provide leadership in regularly scheduled study team meetings with both internal and external resources.
• Act as a liaison for between the study sponsor, the CRO and investigative sites.
• Coordinate the efforts of the project team, including Clinical Research Associates, Clinical Specialists, Global Site Development, Contracts Management, etc.
• Work closely with the Director of Clinical Trials 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, as needed.
• Responsible for achieving study objectives by working with team members to set project priorities and milestones and resolve project conflicts.
• Respond promptly and appropriately to study issues raised by investigative sites, sponsors, monitors and consultants.
• Participate in the analysis, summary and reporting of clinical data for regulatory or marketing purpose throughout the course of the study.

 

Requirements/Qualifications:

• Minimum of Masters in Health, Life Sciences or Biomedical Engineering required.
• Previous experience in the conduct of clinical studies, preferably in the medical device industry.
• Working knowledge of FDA and other regulatory requirements that may impact global clinical studies.
• Conscientious, influential person with an outstanding work ethic and strong personal discipline.
• Willingness and capability to handle multiple projects and responsibilities.
• Excellent organizational, leadership and problem-solving skills.
• Excellent written and verbal communication skills.

Other:

Benefits include 401k and profit sharing plans as well as 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.