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Regulatory Submissions (Study Start-up) Manager
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Regulatory Submissions (Study Start-up) Manager

Job Snapshot

Employment Type Full-Time
Job Type Health Care
Education Not Specified
Experience Not Specified
Manages Others Yes
Industry Healthcare - Health Services
Required Travel Not Specified
Job ID RSM_Cincinnati

Job Description


  • Efficiently manage and successfully execute all aspects of global start-up according to Sponsor specifications;
  • Perform quality checks on submission documents and site essential documents;
  • Interact with US central IRBs, sites, and international associates;
  • Prepare and approve informed consent forms;
  • Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
  • Present during bid defenses, general capabilities meetings, and audits.

Job Requirements


  • More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
  • Strong oral and written communication skills.

Travel: Minimal


We look forward to receiving your application.  A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.

EO/AA Employer M/F/Disability/Vets

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Regulatory Submissions (Study Start-up) Manager

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