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Clinical Project Manager

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Job Type
Direct Hire
Nov 20, 2018
Job ID
Our 10-person, start-up medical device client is developing a novel, minimally invasive technology in the Twin Cities. This is a newly created position and will be the only Clinical Project Manager reporting to the Director of Clinical. 

Primary Responsibility:

* Drafts clinical trial protocol, protocol amendments, and study reports, as directed. 
* Develops and executes research tracking databases and spreadsheets to provide relevant information for Clinical Studies management.
* Manages clinical study site information
* Monitors Institutional Review Board approvals from study sites to ensure that participating study sites have required approvals 
* Manages and updates study files, as directed.
* Communicates schedules for upcoming patient follow-up visits to the clinical study sites.
* Tracks receipt of proper study documentation (IRB approval letters, Informed Consent materials, signed Clinical Study Agreements, Confidentiality Agreements, etc.)
* Organizes, complies, and distributes clinical study documents.
* Writes routine correspondence with clinical study sites and provides home office coverage for the clinical team.
* Submits memos and protocol amendments to clinical study sites.

Background Profile:

* 3+ years experience as a Clinical Project Manager at a smaller medical device company required.
* Basic knowledge of cardiovascular anatomy.
* Interpersonal and communication skills necessary to interact with study site personnel and physicians.
* Organizational skills and ability to handle multiple priorities in a fast-paced environment.
* Basic skills in Microsoft Office, Word, and Power Point.
* Basic skills in Excel, Access, and clinical database management software.