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Regulatory Submissions (Study Start-up) Manager

Regulatory Submissions (Study Start-up) Manager

Job Description



Medpace is a global, full-service clinical research organization with therapeutic specialization in oncology, cardiovascular, endocrine/metabolic, Infectious disease and CNS. We have steadily expanded operations in nearly forty countries. Headquarters are located in Cincinnati, Ohio with other US offices in Dallas, Texas and Minneapolis, Minnesota.

Our clinical operations activities are growing rapidly and we are currently seeking office-based Regulatory Submissions Manager. This position will work closely with our global regulatory submissions team; acting as a leader on projects and managing a team.

 

 

DESCRIPTION OF JOB DUTIES

 

 

  • 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

QUALIFICATIONS/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


WHAT TO EXPECT NEXT


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

Job Snapshot

Employment Type Full-Time
Job Type Biotech, Pharmaceutical, Health Care
Education Not Specified
Experience At least 5 year(s)
Manages Others Yes
Industry Biotechnology, Pharmaceutical, Healthcare - Health Services
Required Travel Not Specified
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Regulatory Submissions (Study Start-up) Manager


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