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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 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 who have experience with IVD. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory requirements and good clinical practices. We recommend practising common interview questions related to clinical study management to show you’re the right fit for the role.
✨Tip Number 3
Showcase your experience with clinical monitoring tools and documentation during interviews. Bring examples of how you've managed studies within budget and on time, as this will highlight your ability to handle the responsibilities of a Clinical Study Lead.
✨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 is tailored to the Clinical Study Lead role. Highlight your IVD experience and any relevant clinical study management skills. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this temporary role. Share specific examples of your past experiences that relate to the job description, especially around compliance and study management.
Showcase Your Regulatory Knowledge: Since regulatory knowledge is key for this position, make sure to mention your familiarity with FDA CFR, ICH GCP, and other relevant guidelines. We love seeing candidates who understand the ins and outs of clinical regulations!
Apply Through Our Website: Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it makes the whole process smoother for everyone involved.
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 terms of 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 implemented study-specific monitoring tools or handled site visits, and be ready to share these stories.
✨Communication is Key
Since you'll be coordinating with various stakeholders, practice articulating your thoughts clearly. Prepare to discuss how you've facilitated communication between teams in the past, and how you plan to keep everyone informed during the study process.
✨Be Ready for Problem-Solving
Anticipate questions about how you've dealt with challenges in previous studies. Think of scenarios where you had to troubleshoot issues or escalate potential problems, and be prepared to explain your thought process and the outcomes.
