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- Tasks: Lead clinical quality management and ensure compliance in groundbreaking healthcare solutions.
- Company: Join a family-owned company with over a century of innovation in healthcare.
- Benefits: Competitive salary, diverse team, and opportunities for professional growth.
- Why this job: Make a real impact on patients' lives through quality assurance in clinical trials.
- Qualifications: 5+ years in Clinical Quality oversight and strong communication skills required.
- Other info: Dynamic work environment with a commitment to diversity and innovation.
The predicted salary is between 36000 - 60000 £ per year.
Join to apply for the Clinical Quality Manager role at HRM - Delivering Leadership Talent. For over a century and five generations, this family-owned company has been dedicated to improving lives through innovative healthcare solutions, particularly in hormonal treatments for women's and men's health. Now seeking a Clinical Quality Manager (GCP), the company continues to build on its legacy of pioneering breakthroughs.
Over the past 20 years, they have expanded into a global operation with a direct presence in 22 countries and a multicultural team of 1,500 employees worldwide - having doubled in size in recent years. Generating $500 million in annual revenues, their remarkable growth is driven by a commitment to innovation, diversity, and a deep understanding of what truly matters to patients and their families.
The Position
- Develop and maintain an effective clinical quality management system to oversee investigational sites and vendors.
- Collaborate with cross-functional teams (Clinical Operations, Project Management Office, Medical, Regulatory, Pharmacovigilance, etc.) to support clinical trial programs for both new products and new indications of marketed products.
- Ensure GCP/ICH-compliant systems and processes are established and maintained to uphold the quality of clinical trials conducted globally and locally, as needed.
- Contribute to the development, review, and continuous improvement of clinical processes and Standard Operating Procedures (SOPs).
- Monitor adherence to applicable SOPs, guidelines, and regulatory requirements across clinical activities.
- Oversee inspection readiness efforts, including planning and coordination of inspection-related activities.
- Assess and qualify Clinical Research Organizations (CROs) and other vendors involved in clinical operations.
- Develop audit plans, and conduct investigator site audits to ensure compliance with protocols, Good Clinical Practice (GCP), and applicable regulations.
- Oversee CRO and investigator monitoring activities to ensure alignment with protocols, GCP, regulatory requirements, and internal policies.
- Manage quality records, including change controls, investigations, deviations, and Corrective and Preventive Actions (CAPAs), ensuring timely resolution and closure.
The Person
- Bachelor's Degree (Science discipline preferred).
- 5+ years' experience in a Clinical Quality oversight role.
- Clinical QA experience in the pharmaceutical industry essential.
- Experience in audits and/or quality oversight processes in GxP areas.
- Experience carrying out regulatory inspections.
- You work independently as well as collaboratively with cross functional teams.
- Strong communication skills both written and verbal.
- Excellent presentation and training skills.
To learn more about this role apply online or contact Anita Osibuamhe on +44 (20) 3769 7178 for a confidential discussion.
Clinical Quality Manager in London employer: HRM - Delivering Leadership Talent
Contact Detail:
HRM - Delivering Leadership Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Quality Manager in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the healthcare and pharmaceutical sectors. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by researching the company’s recent projects and values. Show them you’re not just another candidate; you’re genuinely interested in their mission and how you can contribute.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to clinical quality management. We all know that confidence is key, so rehearse until you feel ready to shine!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’ve got some great resources to help you along the way.
We think you need these skills to ace Clinical Quality Manager in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Clinical Quality Manager role. Highlight your relevant experience in clinical quality oversight and any specific achievements that align with the job description.
Craft a Compelling Cover Letter: Your cover letter should tell your story! Explain why you're passionate about clinical quality management and how your background makes you a perfect fit for HRM. Don’t forget to mention your collaborative skills!
Showcase Your Skills: In your application, emphasise your strong communication and presentation skills. These are key for the role, so give examples of how you've used them effectively in past positions.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our team!
How to prepare for a job interview at HRM - Delivering Leadership Talent
✨Know Your GCP Inside Out
As a Clinical Quality Manager, you'll need to demonstrate a solid understanding of Good Clinical Practice (GCP) and ICH guidelines. Brush up on these regulations and be ready to discuss how you've applied them in your previous roles.
✨Showcase Your Collaborative Spirit
This role involves working with cross-functional teams, so highlight your experience in collaboration. Prepare examples of how you've successfully partnered with Clinical Operations, Project Management, or other departments to enhance clinical trial quality.
✨Prepare for Inspection Readiness Questions
Since overseeing inspection readiness is key, think about your past experiences with regulatory inspections. Be ready to share specific instances where you ensured compliance and how you handled any challenges that arose during audits.
✨Demonstrate Continuous Improvement Mindset
The company values innovation and improvement, so come prepared with ideas on how to enhance clinical processes and SOPs. Discuss any initiatives you've led or contributed to that resulted in better quality management or operational efficiency.
