Job Snapshot
Location:
56 E Bell Dr
Warsaw, IN 46582
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Industry:
Biotechnology
Healthcare - Health Services
Manufacturing
Job Type:
Health Care
Research
Experience:
At least 2 year(s)
Contact Information
Description
Job Summary: Position is responsible for supporting pre market clinical research efforts for Biomet Biologics at the Warsaw facility. Responsibilities include management of all aspects of pre-market clinical research.
Essential Duties:
1. Create and submit clinical protocols and budgets.
2. Follow procedures for the Clinical Research Department and train investigator sites on proper procedures. Duties include: Study management, annual reports, corresponding with study sites, audits of study sites (travel required), billing, certifications and compliance with Biomet’s SOPs.
3. Manage implementation of studies and ongoing study activities.
4. Conduct Investigator meetings and correspond with investigational sites.
5. Compile Post-Market Surveillance plans.
6. Ensure maintenance of data and record keeping.
7. Register and maintain registrations on clinicaltrials.gov.
8. Create Needs Assessment Documents.
9. Follow all internal SOPs including Compliance SOPs and procedures as well as fill requests from the Compliance department.
10. Travel will be required.
11. Performs related duties as required.
Requirements
Job Specifications: Requires the ability to
- Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
- Ability to effectively present information to investigators.
- Ability to understand clinical data collection and some statistical understanding.
Skills And Abilities: Knowledge and skills identified are typically acquired by completing Bachelor’s degree in health, engineering, or a science related field. Two years of practical medical device regulatory/clinical experience preferred. Excellent computer skills required, including Microsoft Excel and Word.
Biomet offers excellent compensation, health care and retirement benefits. Only resumes with salary history will be considered. For confidential consideration, submit resume with salary history to: [Click Here to Email Your Resumé].
Biomet is an Equal Opportunity Employer.
