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Clinical Investigations SME

Job Posted: 2 days ago

Salary: £ 45 - 45 / Hour
Job Type: Contract
Location: Welwyn Garden City, Hertfordshire

Expire in: 25 days

Job Description

Adecco / Pontoon is an employment consultancy. We put expertise, energy, and enthusiasm into improving everyone's chance of being part of the workplace. We respect and appreciate people of all ethnicities, generations, religious beliefs, sexual orientations, gender identities, and more. We do this by showcasing their talents, skills, and unique experience in an inclusive environment that helps them thrive.

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

Before You Apply

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Looking for your next career move? Join a top company hiring Clinical Investigations SME job near me in Welwyn Garden City, Hertfordshire! This is your chance to work on exciting projects, grow professionally, and enjoy a rewarding career with competitive pay and excellent benefits. Whether you're an experienced professional or looking to take the next step, this role offers the perfect opportunity to enhance your skills and make an impact. Don’t miss out—apply today via Vita CV and take your career to the next level!