Austin Categories:
Director or Manager of Clinical Studies LDR Spine USA, Inc.
THIS JOB HAS EXPIRED
Job DescriptionMust work to ensure that LDR Spine is in compliance with 'Regulations' (e.g., GCP), 'Standards' (e.g., ISO 13485) and the Quality Manual.
Manage/Direct an ongoing IDE/PAS study of a Class III PMA product.
Manage/Direct the design, implementation, and operations of new retrospective and prospective clinical studies to support regulatory submissions and marketing needs. This includes protocol development, site identification/training/initiation, enrollment, follow-up, data collection, and analysis.
Develop and maintain professional relationships with academic and community based physicians, surgeons, clinicians, and study coordinators to assure the end result is the highest quality clinical study work.
Work closely with Clinical Research, Regulatory, and Marketing to (1) ensure the upfront goals of clinical studies will meet strategic goals for research deliverables, and (2) to develop the deliverables based on the results of the clinical studies.
Manage/Direct the data collection and data analysis workflows, including internal staff.
Provide updates and status reports to senior management on a regular basis. Excellent presentation and communication skills are required.
Proactively identify issues and hurdles that may negatively impact project goals, budget, or timeline. Work diligently to find creative solutions and alternative strategies.
Responsible for monitoring US FDA regulations and implementing changes as needed.
Develop and implement SOPs for clinical studies and related activities.
Strong project planning skills, leadership/ownership skills, and a demonstrated passion for details.
Must possess a Can-Do attitude, and be willing to work hard to meet company goals. The candidate will encounter challenges requiring both a high level of Emotional Intelligence, as well as the need to find creative solutions. Effective communication skills in a fast paced work environment are required.
Other duties as assigned.
Requirements
Bachelors Degree in Engineering or Life Science (advanced degree preferred)
Minimum of 8 years (Manager) or 10 years (Director) in Clinical Affairs, with an emphasis on clinical study project management.
Minimum of 3 years in the medical device industry.
Experience in orthopedic and/or spine is desired.
Established track record of managing/directing all operational and logistical tasks of clinical study development and execution within established budgets and timelines.
Experiencing managing/directing efforts of internal and external resources to ensure studies are initiated and completed with efficiency and timeliness.
Experience working under USA clinical study and clinical research regulations.
Experience with FDA regulated clinical trials, including pre-market and post-market studies, and a demonstrated knowledge of the importance of patient follow-up to long term study needs.
Experience building a team to initiate and execute the requirements of clinical studies.
Experience managing direct reports and budget responsibilities.
A demonstrated track record of attention to detail, a passion for efficiency, and the desire to complete projects on time.
| Location: | 13785 Research Boulevard Suite 200 Austin, TX 78750 United States |
|---|---|
| Full Time | |
| Engineering / Product Dev / Science | |
| Clinical Engineering Life Science Orthopedic Spine FDA trials |
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 |
