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- Tasks: Lead quality assurance for clinical trials, ensuring compliance and safety standards.
- Company: Join WEP Clinical, a mission-driven organisation transforming lives through innovative clinical research.
- Benefits: Enjoy private healthcare, generous leave, and a supportive work environment focused on wellness.
- Why this job: Be part of a dynamic team making a real difference in patient care and clinical outcomes.
- Qualifications: Bachelor’s degree and 7+ years in clinical research with a focus on quality assurance required.
- Other info: WEP Clinical values diversity and offers a smoke-free, drug-free workplace.
The predicted salary is between 43200 - 72000 £ per year.
Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.
Role Objectives: The Senior Clinical Quality Assurance Manager at WEP Clinical oversees the maintenance and compliance of the Quality Management System, ensuring adherence to quality principles and Good Clinical Practice (GCP) regulatory requirements. This role supports key stakeholders across global clinical operations, including clinical trial management and the patient-enabling solutions group, which encompasses home health solutions, virtual clinical trials, patient concierge services, and patient recruitment. Additionally, the Senior Clinical Quality Assurance Manager is responsible for developing, implementing, and maintaining quality assurance standards and processes to uphold the safety, efficacy, and ethical conduct of clinical trials in compliance with GCP.
The Ideal Candidate:
- Decisive and strategic leader
- Adaptable and solution-oriented
- Detail Oriented and analytical
- Strong interpersonal skills
What You'll Do:
- Develop, implement, and maintain a comprehensive quality assurance framework for clinical services, ensuring compliance with GCP, FDA, EMA, and internal standards
- Manage quality records and processes, including deviations, change controls, CAPAs, complaints, and other quality incidents
- Conduct risk assessments to identify and mitigate potential quality risks in nursing and clinical services
- Perform audits and inspections to assess compliance, identify non-conformances, and implement corrective actions
- Host external client and regulatory inspections, coordinating audits and responses
- Monitor, develop, and deliver training on quality assurance principles, regulatory requirements, and SOPs
- Oversee external vendors to ensure compliance with quality standards and regulatory requirements
- Ensure compliance with regulatory requirements, including GCP, data privacy laws (e.g., GDPR), and local regulations
- Identify and implement process improvements to enhance the quality and efficiency of clinical services and home health solutions
- Serve as the key quality contact for projects, supporting setup and liaising with clients as needed
What You'll Need:
- Bachelor’s degree or higher, preferably in pharmaceutical sciences, life sciences, or nursing
- 7+ years of experience in clinical research with a focus on quality assurance and/or clinical services
- In-depth knowledge of clinical trial methodologies, regulatory requirements, and GCP guidelines
- Experience with decentralized clinical trials and remote patient monitoring is a plus
- Demonstrated expertise in developing and implementing quality assurance systems, change management, and processes
What We Offer:
- Private healthcare insurance
- Long-term illness cover
- Death in service cover
- Salary sacrifice pension
- Annual leave
- Paid maternity & paternity leave
- Volunteer day
What Sets Us Apart: WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
We're Committed to Our Team: WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.
We're Committed to DEI: At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.
Our services include:
- Access Programs
- Clinical Trial Services
- Patient Site Solutions
- Clinical Trial Supply
- Market Access and Commercialization
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment. WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
Senior Clinical Quality Assurance Manager employer: WEP Clinical
Contact Detail:
WEP Clinical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Clinical Quality Assurance Manager
✨Tip Number 1
Familiarise yourself with Good Clinical Practice (GCP) guidelines and regulatory requirements like FDA and EMA. This knowledge will not only help you in interviews but also demonstrate your commitment to quality assurance in clinical trials.
✨Tip Number 2
Network with professionals in the clinical research field, especially those who have experience in quality assurance. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the sector.
✨Tip Number 3
Showcase your leadership skills by discussing any previous experiences where you led a team or project related to quality assurance. Highlighting your ability to manage and mentor others can set you apart from other candidates.
✨Tip Number 4
Research WEP Clinical’s mission and values thoroughly. Understanding their commitment to patient care and innovative solutions will allow you to align your answers during interviews with their organisational goals, making you a more attractive candidate.
We think you need these skills to ace Senior Clinical Quality Assurance Manager
Some tips for your application 🫡
Tailor Your CV: Make sure to customise your CV to highlight relevant experience in clinical quality assurance and compliance with GCP. Use specific examples that demonstrate your leadership and analytical skills.
Craft a Compelling Cover Letter: Write a cover letter that reflects your passion for clinical research and your understanding of the role's objectives. Mention how your background aligns with WEP Clinical's mission and values.
Highlight Relevant Experience: In your application, emphasise your 7+ years of experience in clinical research, particularly focusing on quality assurance. Include any specific projects or achievements that showcase your expertise in developing quality assurance systems.
Showcase Soft Skills: WEP Clinical values strong interpersonal skills and adaptability. Be sure to include examples of how you've successfully collaborated with teams or managed stakeholders in previous roles.
How to prepare for a job interview at WEP Clinical
✨Showcase Your Leadership Skills
As a Senior Clinical Quality Assurance Manager, you'll need to demonstrate your ability to lead and make strategic decisions. Prepare examples from your past experiences where you successfully led a team or project, highlighting your decisiveness and adaptability.
✨Understand GCP and Regulatory Requirements
Make sure you're well-versed in Good Clinical Practice (GCP) and other regulatory requirements like FDA and EMA guidelines. Be ready to discuss how you've implemented these standards in previous roles and how you can ensure compliance at WEP Clinical.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and ability to handle quality incidents. Think of specific scenarios where you identified risks or non-conformances and the steps you took to address them effectively.
✨Emphasise Your Interpersonal Skills
Strong interpersonal skills are crucial for this role, especially when liaising with clients and stakeholders. Be prepared to discuss how you've built relationships in the past and how you plan to foster collaboration within the team at WEP Clinical.
