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- Tasks: Lead quality and risk oversight for clinical trials, ensuring first-time quality and robust risk management.
- Company: Join Parexel, a leading company in the CRO industry, dedicated to improving patient outcomes.
- Benefits: Enjoy flexible working hours, competitive salary, bonuses, and a comprehensive benefits package including healthcare.
- Why this job: Be part of a dynamic team, mentor new talent, and contribute to impactful clinical research.
- Qualifications: Bachelor’s degree or relevant experience; strong communication and analytical skills required.
- Other info: Work at Northwick Park Hospital with opportunities for career development and continuous improvement.
The predicted salary is between 42000 - 66000 £ per year.
Due to a growing portfolio, we are currently looking for Project Quality and Risk Lead to be based in London with flexible working hours. This position requires being at the Clinical Unit (Northwick Park Hospital) initially 1/2 day per week as agreed with Line Manager.
The Project Quality & Risk Lead is responsible for leading quality and risk oversight for clinical trials within the Early Phase Clinical Units. Reporting into the regional Manager, this role ensures first-time quality, robust risk and issue management and inspection readiness by collaborating with operational teams and clients.
Key duties include:
- Facilitating risk assessments, managing quality events, supporting audits and inspections, and providing expert guidance on regulatory compliance.
Key Responsibilities
- Client Liaison & Communication: Act as the main contact for client quality representatives. Respond to urgent quality requests and facilitate quality-to-quality meetings.
- Risk Management: Lead risk identification and mitigation processes. Develop and assess risk mitigation strategies and quality tolerance limits.
- Quality Event Management: Triage and classify quality issues. Facilitate root cause analysis (RCA) and corrective/preventive actions (CAPA).
- Inspection Readiness: Conduct Inspection Readiness Checks (IRCs). Support audit/inspection preparation and response.
- Quality Consultancy: Provide real-time quality advice. Review SOP deviations and consult with SMEs.
- Documentation & Storyboards: Ensure inspection-ready documentation. Oversee storyboard development and updates.
- Continuous Improvement: Identify and propose process improvements. Participate in quality system enhancements.
- Mentorship: Mentor and train new PQRLs.
Knowledge And Experience
- Strong communication and interpersonal skills.
- Ability to manage workload independently and in a matrix environment.
- Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research.
- Experience in clinical research (CAPA management and ICH-GCP standards) is essential.
- Experience with root cause analysis tools (e.g., 5 Whys, Fishbone).
Education
- Bachelor’s Degree or other relevant experience required. Life-science, health or industry-related discipline preferred.
In return we will be able to offer you a structured career pathway and encouragement to develop within the role including awareness and understanding of the industry. You will be well supported and for your hard work you will be rewarded with a competitive base salary, bonus as well as a benefits package including holiday, private healthcare, dental insurance as well as other benefits that you would expect with a top company in the CRO Industry.
Apply today to begin your Parexel journey!
Project Quality and Risk Lead employer: Parexel
Contact Detail:
Parexel Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Project Quality and Risk Lead
✨Tip Number 1
Familiarise yourself with the latest ICH-GCP standards and Good Practices (GxPs) relevant to clinical trials. This knowledge will not only help you in interviews but also demonstrate your commitment to quality and compliance.
✨Tip Number 2
Network with professionals in the clinical research field, especially those who have experience in quality management. Engaging with them can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed risk and quality events in previous roles. Being able to articulate your experience with root cause analysis and corrective actions will set you apart.
✨Tip Number 4
Showcase your mentorship skills by highlighting any experience you have in training or guiding others. This is a key aspect of the role, and demonstrating your ability to support new team members will be beneficial.
We think you need these skills to ace Project Quality and Risk Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical research, quality management, and ICH-GCP standards. Use specific examples that demonstrate your analytical and problem-solving skills.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the Project Quality and Risk Lead role. Mention how your background aligns with the key responsibilities, such as risk management and quality event management.
Showcase Your Communication Skills: Since strong communication is essential for this role, provide examples in your application of how you've effectively liaised with clients or led teams in previous positions.
Highlight Continuous Improvement Initiatives: Discuss any past experiences where you identified process improvements or contributed to quality system enhancements. This will show your proactive approach and commitment to excellence.
How to prepare for a job interview at Parexel
✨Understand the Role Thoroughly
Before your interview, make sure you have a solid grasp of the Project Quality and Risk Lead responsibilities. Familiarise yourself with key duties like risk management, quality event management, and inspection readiness to demonstrate your knowledge and enthusiasm.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and experience in clinical research. Prepare examples from your past work where you successfully managed quality issues or led risk assessments, using specific tools like root cause analysis.
✨Showcase Your Communication Skills
As this role involves liaising with clients and operational teams, be ready to discuss how you effectively communicate complex information. Highlight any experiences where your communication skills made a significant impact on project outcomes.
✨Demonstrate Continuous Improvement Mindset
Discuss your approach to identifying process improvements and how you've contributed to quality system enhancements in previous roles. This will show your commitment to ongoing development and alignment with the company's goals.
