Clinical Research Scientist - Device Ortho
@ Red Nucleus

Hybrid
$120,000
Hybrid
Full Time
Posted 1 day ago

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XXXXXXXXX XXXXXXXXXXX XXXXXX****** @rednucleus.com
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Job Details

Overview

The Clinical Research Scientist - Device Ortho will develop post-market clinical research strategies for orthopedic devices to support global regulatory and post-market surveillance requirements.

About Red Nucleus

Red Nucleus is dedicated to advancing knowledge to improve lives. The company provides strategic learning and development, scientific advisory services, medical communications solutions, and more for the life sciences industry using a global team of nearly 1,000 professionals. Recognized as a "Great Place to Work", Red Nucleus fosters a culture of community, meaning, and fun.

Responsibilities

  • Collaborate with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) on clinical evidence generation strategies.
  • Facilitate clinical evidence reviews and document decisions and risks.
  • Develop and write high quality Post-market Clinical Follow-up (PMCF) plans and reports.
  • Support drafting of clinical study protocols, registry plans, epidemiology studies, and other study materials.
  • Review technical documentation including Clinical Evaluation Plans and Reports, and Post Market Surveillance Plans.
  • Foster relationships with surgeons, hospitals, and research teams for study design and execution.
  • Work with contracts teams for timely study agreements and milestone payments.
  • Support internal clinical scientific discussions to drive and communicate evidence needs.
  • Contribute to the dissemination of clinical evidence including abstracts, manuscripts, and study reports.
  • Develop an understanding of the orthopedic device product portfolio and business clinical evidence needs.

Qualifications

  • A Master’s degree in Biological Science or related discipline.
  • Minimum of 4 years’ experience in the medical device industry or healthcare field.
  • Advanced technical writing skills with experience in PMCF plans/reports.
  • Clinical expertise in the medical device sector with proven experience in clinical studies and registries in orthopaedics.
  • Strong project management skills and excellent communication skills.

Key skills/competency

  • Clinical Research
  • Post-market Surveillance
  • Orthopedic Devices
  • PMCF Plans
  • Technical Writing
  • Regulatory Strategy
  • Clinical Studies
  • Project Management
  • Team Collaboration
  • Evidence Generation
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How to Get Hired at Red Nucleus

🎯 Tips for Getting Hired

  • Customize your resume: Tailor your clinical research and regulatory expertise.
  • Highlight project management: Emphasize multiple project handling skills.
  • Showcase technical writing: Include PMCF and report writing examples.
  • Research Red Nucleus: Understand their culture and clinical evidence strategies.

📝 Interview Preparation Advice

Technical Preparation

Review PMCF planning methodologies.
Study clinical protocol development.
Update regulatory guidelines knowledge.
Practice technical writing clarity.

Behavioral Questions

Describe teamwork experience in clinical projects.
Explain handling multiple simultaneous projects.
Share examples of effective communication.
Discuss problem solving in clinical studies.

Frequently Asked Questions