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- Tasks: Lead clinical studies, manage documentation, and ensure compliance with regulations.
- Company: Oxford Global Resources, a leader in clinical research staffing.
- Benefits: Competitive pay, flexible working hours, and valuable industry experience.
- Why this job: Make a real impact in healthcare while developing your skills in a dynamic environment.
- Qualifications: Bachelor's degree in life sciences and 5-8 years of relevant experience required.
- Other info: Join a supportive team and gain hands-on experience in clinical study management.
The predicted salary is between 36000 - 60000 £ per year.
Oxford Global Resources is hiring a Clinical Study Lead (IVD experience is a must) for temporary maternity leave.
As a Clinical Study Lead/Trial Manager you will be responsible for the development and execution of all study associated documentation including protocols, investigator brochure, informed consent, contracts, and reports, in compliance with relevant regulations, guidelines and SOPs.
The Trial Lead is responsible for creating and implementing study-specific clinical monitoring tools and documents; responsible for managing and tracking of clinical studies and budget, ensuring study completion in a timely manner within budget, escalating potential issues, setting up internal and external communications for correction, trouble shooting, and prevention planning.
Also:
Accountable for ensuring study site preparation, equipment, and training are compliant to the clinical protocol and organization’s SOPs.
Responsible for clinical study data entry and audit; adherence to all regulations including patient privacy per organizational policies.
Coordinating and supervising clinical monitoring team.
Providing Clinical Research Associates with project-specific training and having regular meetings with them.
Arranging and overseeing site visits. Accountable for managing site auditing or QC visits where necessary to address or improve quality.
Accountable for study close out procedures on study binders, datasets and study supplies working with CTAs, CRAs and Data / Statistic stakeholders for close-out documents and reviews.
Authors clinical study reports and study related submission documents to regulatory authorities, IRBs and local agencies in line with their requirements.
Accountable for supplementing data or documents for any queries from authorities during submission procedures.
Support CA function input for studies during audits e.g. BIMO, Pharma partner, FDA.
Education:
- Bachelor’s degree in, life sciences, biomedical engineering or nursing
- 5-8 years working experience with in vitro diagnostic devices company.
- Minimum 3 years working experience in Clinical Affairs/Operations is preferred, but experience in product development, quality and regulatory will be considered as part of overall professional experience.
- Working experience in clinical study management including good clinical practice is preferred . Yes
- Working knowledge of Regulatory requirements e.g. FDA CFR, ICH GCP, ISO14155, IVDR.
- Proficient with Microsoft Office Word and Excel.
- Understanding of Electronic Data Capture (eDC), eTMF and CTMS or similar clinical operations systems.
- Proficient English oral and written communication.
Clinical Study Lead (6 month project contractor) employer: Oxford Global Resources
Contact Detail:
Oxford Global Resources Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Study Lead (6 month project contractor)
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, especially those with IVD experience. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory requirements and good clinical practices. We recommend creating a cheat sheet of key points to discuss, so you can impress the hiring managers with your expertise.
✨Tip Number 3
Showcase your project management skills! Be ready to share examples of how you've successfully managed clinical studies in the past. Use specific metrics to highlight your achievements, like staying within budget or completing studies ahead of schedule.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Clinical Study Lead (6 month project contractor)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your IVD experience and any relevant clinical study management skills. We want to see how your background aligns with the role, so don’t be shy about showcasing your achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for the Clinical Study Lead position. Be specific about your experience with clinical protocols and regulations, and let us know what excites you about this opportunity.
Showcase Your Communication Skills: Since the role involves coordinating with various teams, make sure to highlight your communication skills in your application. Whether it’s through your writing style or examples of past collaborations, we want to see how you can effectively engage with others.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team at StudySmarter!
How to prepare for a job interview at Oxford Global Resources
✨Know Your Stuff
Make sure you brush up on your IVD experience and relevant regulations like FDA CFR and ICH GCP. Be ready to discuss how your past roles align with the responsibilities of a Clinical Study Lead, especially in managing clinical studies and ensuring compliance.
✨Showcase Your Project Management Skills
Prepare examples that highlight your ability to manage budgets, timelines, and teams effectively. Think about specific projects where you successfully navigated challenges and how you ensured timely completion within budget.
✨Communicate Clearly
Since you'll be coordinating with various stakeholders, practice articulating your thoughts clearly. Use examples from your experience to demonstrate how you've facilitated communication between teams and handled site visits or audits.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's current projects and their expectations for the Clinical Study Lead role. This shows your genuine interest and helps you gauge if the company culture aligns with your values.
