Senior Clinical Research Scientist

JOB DESCRIPTION:

The Opportunity:

Organize and conduct, or participate in, all performance evaluations for new products, product enhancements, and product process changes. Participate as the clinical resource on product development teams, working with R&D, Regulatory Affairs, Quality Assurance and Marketing in identifying user needs and market segments, and presenting relevant evaluation results as necessary.
What you’ll do:

• Provide clinical knowledge and expertise in clinical study protocol development, clinical trial design, analysis and interpretation
• Solid performance in creating high quality, scientifically sound and medically accurate documents that are clear and focused for clinical research and regulatory agency submissions (such as FDA).
• Expertise with health care and medical communication and effective use of on-line research databases, such as Pubmed, and use of integrated referencing software.
• Evaluates new product ideas and business opportunities by reviewing pertinent literature and other available information, summarizing information and making recommendations to appropriate departments.
• Scientific review and input to CRF development. Excellent collaboration skills with biostatistics and data management.
• Participates in the Risk Analysis process for new or improved devices to ensure that potential risks to patients associated with use of the device and risks to study execution are identified and appropriately analyzed.
• Creates clinical performance evaluation plans to assess physician acceptance and the expected performance of new products by interacting with appropriate personnel, (e.g., physicians, engineers, other clinical coordinators, regulatory affairs).
• Cultivates relationships with internal and external customers, (e.g., consultants and investigators) to continue to grow their expertise in clinical research.
• Writes device Instructions for Use (IFU).
• Provide clinical knowledge, expertise and direction relevant to manufacturing, quality, performance and patient safety during all phases of development of a product or concepts to ensure informed decisions are made in these areas.
• Support product development by contributing clinical knowledge to bench testing, performing in-vitro and /or in-vivo device evaluations and assisting in the development of new test methods to provide a better understanding of device performance.
• Coordinate and conduct post-market clinical evaluations of new product designs or enhancements.
• Participates in Product Action process by performing and documenting a Health Risk Assessment and communicating the assessment to Quality Assurance.

Required Qualifications:

• Bachelor’s Degree in Biological Science or similar with a minimum of 9 years of related work experience with a complete understanding of specified functional area.  Master’s Degree is preferred.
• Comprehensive knowledge and application business concepts, procedures and practices.
• Uses in-depth knowledge of business unit functions and cross group dependencies/
  relationships.
• Is recognized as an expert in work group. Will perform this job in a quality
  system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Has broad knowledge of various technical alternatives and their potential impact on the business.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

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