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Senior Clinical Project Manager

Summary Overview:

Manage clinical studies in compliance with appropriate medical device and clinical practice laws and regulations in order to obtain clinical data to support both new and existing products.  Provide support and input for post market studies.  Provide work direction, manage and train clinical staff as well as contractors.

Responsibilities:

  • Determine clinical study objectives, strategy, scope, budget and schedule in order to meet needs. Research, prepare and revise Clinical Investigational Plan in collaboration with key clinicians, regulatory agencies and internal personnel.
  • Execute clinical Studies in compliance with applicable regulations, Good Clinical Practices, SOPs and study timelines. Collect, analyze and summarize clinical data for submission to regulatory agencies for product approvals and marketing purposes.
  • Train clinical investigators and support staff on clinical protocols. Conduct site qualification visits, monitoring visits and closeout visits to ensure completeness and accuracy of collected data and site compliance.
  • Administrative Duties

Qualifications:

  • Minimum of a bachelor’s degree in scientific field and three years clinical trial experience.
  • Advanced knowledge of good Clinical Practices and Regulatory and compliance guidelines for clinical trials in the United States, European Union and other major regulated countries.
  • Ability to multi-task and direct several studies at the same time.
  • Advanced written and oral communication skills, with medical terminology.
  • Ability to develop relationships with and interact effectively with physicians, and study coordinators.
  • Ability to work and collaborate effectively with co-workers in various departments.
  • Strong team participation and team management skills.
  • Willingness to travel an average of 30%.
  • Computer skills include word processing, spreadsheet, database management and Internet.

 

Job Status: Full Time

Compensation: DOE

Job Location: St. Paul, MN 55114


Contact Information:

Lori Chmiel
Senior Executive Recruiter
952-847-3287
Lori.chmiel@engageitresources.com

 

                                                      

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