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- Tasks: Support quality in clinical trials and ensure patient safety and compliance.
- Company: Global healthcare leader with a rich 125-year legacy of innovation.
- Benefits: Competitive salary, career growth, and the chance to make a real impact.
- Why this job: Join a mission-driven team dedicated to advancing global healthcare.
- Qualifications: Bachelor's degree and 4-6 years in clinical research required.
- Other info: Dynamic role with opportunities for continuous improvement and training.
The predicted salary is between 45000 - 55000 £ per year.
Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
We are looking for an Associate Country Clinical Quality Manager to support the quality of clinical trials conducted by the Clinical Trials Operations in the UK. It is critical that, for all our sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The Associate CCQM position has an important impact in achieving those objectives.
The Associate CCQM supports the oversight of specific CQM activities in the respective country/cluster under the guidance of the Director, Country Clinical Quality Management Lead (CCQM‑L) and in close collaboration with the Country Clinical Quality Manager (CCQM). The role requires the ability to properly support the implementation of local/global processes and procedures, to identify opportunities for process improvement and to lead continuous improvement initiatives. In addition, the Associate CCQM supports audits, inspections, quality control and local training activities.
Qualifications
- Bachelor's Degree or equivalent in relevant health care area.
Experience
- A minimum of 4‑6 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments.
- Knowledge and understanding of Clinical Trial processes as well as quality management and control tools.
- Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
- Experience participating in cross‑functional teams of business professionals; leading a cross‑functional team is a plus.
- Experience participating in audits and inspections, preferably with direct support.
- Experience coordinating and delivering training sessions.
Skills
- Superior oral and written communication skills in an international environment.
- Good project management, organizational and prioritization skills.
- Good teamwork and leadership skills, including the ability to resolve conflicts.
- Ability to analyze, interpret, and solve problems.
- Ability to think objectively and with creativity and innovation.
Regulations & Processes
- Local expert for ICH‑GCP and local regulations, including impact assessment of new or updated regulations on local processes.
- Collaborates with local country operations management to support the CCQM in managing a network of owners/SMEs for global/local processes, ensuring proper implementation and regular SOP updates.
- Acting local expert for any quality‑related local processes.
- Identifies process gaps or opportunities for improvement and escalates to RCQM or Global Process Owners, as needed.
- Supports continuous quality improvement activities at the country level and at the regional level.
Training
- Supports local trainings as needed.
Quality Control (QC) Activities
- Coordinates and oversees all QC activities, ensuring proper execution of the In‑House Quality Control Plan, Quality Control Visits, and other QC checks.
- Performs QC activities and conducts ad‑hoc site visits upon request.
- Collaborates with local country operations to identify trends, conduct root‑cause analysis, and develop local action plans.
Audits & Inspections
- Supports activities during the preparation, ongoing, and follow‑up phases of an audit or inspection.
- Coordinates root‑cause analysis for audit observations, manages Corrective and Preventive Actions, and facilitates responses to audit/inspection reports.
- Collaborates with local country operations to identify trends, conduct root‑cause analysis, and develop local action plans.
Quality / Compliance Issue Escalation
- Communicates and escalates quality/compliance issues and trends to local country operations and CCQM‑L.
- Escalates significant issues per company process, supports investigations and reports serious breaches if applicable.
- Acting point of contact for privacy breach escalations in clinical trials.
- Evaluates trends on Clinical Supply GCP inquiries and incorrect management of supplies.
- Coordinates GCP investigations related to supply trends.
Local / Regional Initiatives / Projects
- Supports local and regional initiatives projects upon request of the RCQM.
Associate Country Clinical Quality Manager employer: MSD in the UK
Contact Detail:
MSD in the UK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Country Clinical Quality Manager
✨Tip Number 1
Network like a pro! Reach out to professionals in the clinical research field on LinkedIn or at industry events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨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 quality management and compliance. We want you to feel confident and ready to showcase your expertise!
✨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 Associate Country Clinical Quality Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Associate Country Clinical Quality Manager role. Highlight your relevant experience in clinical research and quality management, and don’t forget to showcase any specific achievements that align with the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about clinical quality management and how your skills can contribute to our mission. Keep it concise but impactful, and make sure to address the key responsibilities mentioned in the job description.
Showcase Your Communication Skills: Since superior communication skills are crucial for this role, ensure your application reflects this. Use clear and professional language, and double-check for any typos or grammatical errors. We want to see that you can communicate effectively in an international environment!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, you’ll get to explore more about our company and culture while you’re at it!
How to prepare for a job interview at MSD in the UK
✨Know Your Clinical Trials Inside Out
Make sure you brush up on your knowledge of clinical trial processes and regulations, especially ICH-GCP. Being able to discuss specific examples from your experience will show that you’re not just familiar with the theory but have practical insights to offer.
✨Showcase Your Project Management Skills
Prepare to talk about your project management experience in detail. Highlight any successful projects you've led or been a part of, focusing on how you initiated, planned, and delivered results. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Demonstrate Your Problem-Solving Abilities
Think of instances where you identified process gaps or implemented improvements. Be ready to discuss how you approached these challenges, what actions you took, and the outcomes. This will illustrate your analytical skills and ability to think creatively.
✨Prepare for Teamwork Questions
Since collaboration is key in this role, be prepared to share experiences where you worked in cross-functional teams. Discuss how you resolved conflicts and contributed to team success, showcasing your teamwork and leadership skills.