Clinical Investigations SME

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Job Title: Clinical Investigations SME

Contract: Initial 6 Month Contract

Location: Welwyn Garden City - Hybrid 1 day a week in office

Rate: 45 per hour LTD

Are you passionate about medical device safety and looking to make a significant impact in the clinical investigations field? Our client, a leading organization in the healthcare sector, is seeking a Clinical Investigations Subject Matter Expert (SME) to join their dynamic team. If you possess strong expertise in medical device clinical safety and thrive in collaborative environments, we want to hear from you!

What You'll Do:

As a Clinical Investigations SME, you will play a crucial role in supporting clinical investigations of medical devices. Your responsibilities will include:

• Developing and providing safety input into core clinical investigation documents, such as:
• Clinical Investigation Plans (CIP/Protocol)
• Investigator's Brochure (IB)
• Reference Safety Information (RSI)
• Leading the development of safety deliverables for medical device clinical investigations independently and strategically.
• Collaborating effectively within multifunctional and multicultural teams to ensure a seamless investigation process.

What We're Looking For:

To succeed in this role, you'll need:

• MD Clinical Investigations Expertise: Significant hands-on experience with safety activities in MD clinical investigations, showcasing your practical experience in roles with safety responsibilities.
• ISO 14155:2020 Proficiency: An expert-level understanding and the ability to apply this standard across all phases of MD clinical investigations.
• Document Development Experience: Proven experience in developing and providing safety input for core MD clinical investigation documents, demonstrating your ability to lead the development of these deliverables strategically.

Additional Qualifications:

• Proven experience in MD clinical safety and vigilance.
• Risk Management expertise, including benefit-risk assessment and practical application of ISO 14971.
• Experience with combination products (drug/MD) is a plus.
• A background in drug safety (pharmacovigilance) is an added asset.
• Excellent communication skills and the ability to lead and work collaboratively as a team player.

Education/Background:

We are looking for candidates with a relevant healthcare, scientific, or biomedical research background, coupled with clinical safety experience in using MDs and/or combination products in the pharmaceutical, biotech, or medical device industry. A solid understanding of biomedical technical aspects and relevant MD regulations and industry standards is essential.

Why Join Us?

Our client offers a vibrant work environment where innovation thrives. You will have the opportunity to work on cutting-edge medical devices, contributing to projects that improve patient safety and outcomes. This is your chance to be part of a mission-driven organization that values your expertise and fosters your professional growth!

We use generative AI tools to support our candidate screening process. This helps us ensure a fair, consistent, and efficient experience for all applicants. Rest assured, all final decisions are made by our hiring team, and your application will be reviewed with care and attention.