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Clinical Research Project Manager LDR Spine USA, Inc.
THIS JOB HAS EXPIRED
Job DescriptionAssume responsibility for the preparation of manuscripts for publication, white papers, presentations, clinical posters, documents supporting major regulatory submissions, and other clinical data reports as directed This includes responsibility to independently research, write, edit and manage several projects at once This will require consulting with authors, surgeons, and LDR staff regarding medical/scientific content.
Work with other departments as needed to develop journal articles and marketing materials.
Ensure maintenance of document standardization through the use of model documents/templates and appropriate peer review.
Coordinate with Clinical, marketing, and Operations management to identify goals and scope of clinical study projects. Manage and execute the overall project scope and timelines.
Identify and manage sites and surgeons for clinical research and publication.
Initiate and train sites to the study protocol. Ensure proper site adherence to clinical research regulations.
Conduct site visits prior to and during research projects and provide support to investigators and study coordinators to resolve study related issues.
Prepare and review clinical data for analysis. Manage relationships with consultants to provide adequate support and services for data collection and analysis.
Other duties as assigned.
Requires up to 20-40% travel time.
Desired Skills & Experience
Master of Science degree in Life Sciences, Engineering, or Health Care related field.
Bachelor degree +3 years of experience may suffice in lieu of MS degree. Other applicable experience will be considered.
Must work to ensure that LDR Spine is in compliance with 'Regulations' (e.g., QSR), 'Standards' (e.g., ISO 13485) and the Quality Manual.
3 - 5 years in Medical Device Clinical Research, Product Development, and/or marketing.
Medical Writing experience is required.
Orthopedic/Spine experience preferred.
Demonstrated knowledge of Good Clinical Practices and all applicable U.S. regulations governing clinical research, as well as knowledge of the FDA submission process including IDE, PMA, and 510(k)
Minimum 2 years of experience in data analysis and technical writing for medical devices or equivalent experience (academia, scientific publications, pharmaceuticals, biotechnology).
Advanced knowledge of anatomy and physiology and the ability/desire to learn new anatomic/physiologic principles.
Experience training and presenting to large groups, including investigator teams and company management.
Experience with the publication process for major industry conferences and academic journals.
Demonstrated problem-solving and interpersonal skills. Must have a 'can-do' attitude and a strong desire to take ownership of many different projects.
Excellent communication skills, including experience dealing with decision makers, such as surgeons, hospital staff, IRB members, and FDA staff.
Strong desire to join a small company and work in a fast paced environment. Ability to work independently and manage multiple timelines, while maintaining the Team focus.
Ability to take constructive criticism and apply it to personal/career development. A strong desire to learn from the team and grow into a position of leadership within the company.
Experience in using a computer required. Familiarity with common software programs (e.g., Word, Excel and PowerPoint) required.
| Location: | 13785 Research Boulevard Suite 200 Austin, TX 78750 United States |
|---|---|
| Full Time | |
| Engineering / Product Dev / Science | |
| Research Operations clinical regulations engineering life sciences health care |
THIS JOB HAS EXPIRED
LDR Spine USA, Inc.
LDR works closely with surgeons to develop implantable spine systems and instrumentation that restore optimum stability and mobility to patients and to make spine surgery more reproducible and easier to perform. More information is located at www.ldrholding.com.
Shipping Product 
> 50M RaisedInvestors: Austin Ventures, PTV Sciences, Rothschild Private Equity, Telegraph Hill Partners
All Jobs: at LDR Spine USA, Inc.
| Web Site: | www.ldrholding.com |
|---|---|
| Headquarters: | 13785 Research Boulevard Suite 200 Austin, TX 78750 United States |
| Employees: | >100 |
| 2004 | |
| Industry: | Medical Devices and Equipment |
| Vision: LDR combines passion and innovation to improve spine care. Mission: LDR develops and markets total spine solutions for patients and the surgeon community worldwide. We listen to surgeons and use our technical experience and passion for improvement to create innovative spine products. Founded: 2001- LDR Medical, SAS 2004- LDR Spine USA, Inc. 2006- LDR Holding Corporation Ownership and Financing: Private, Series-C Primary Investors: Austin Ventures, PTV Sciences, Rothschild Private Equity and Telegraph Hill Partners |
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