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- Tasks: Lead quality assurance for clinical trials, ensuring compliance and safety standards.
- Company: WEP Clinical transforms lives through innovative clinical research and patient solutions.
- Benefits: Enjoy private healthcare, paid leave, pension options, and wellness initiatives.
- Why this job: Join a mission-driven team making a real impact in healthcare and clinical research.
- Qualifications: Bachelor’s degree and 7+ years in clinical research with quality assurance focus required.
- Other info: WEP Clinical promotes diversity, equity, and inclusion in a supportive work environment.
The predicted salary is between 48000 - 84000 £ 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.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing
Senior Clinical Quality Assurance Manager employer: WEP Clinical Ltd
Contact Detail:
WEP Clinical Ltd 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 the specific regulatory requirements relevant to the role. 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 quality assurance field, especially those who have experience with decentralized clinical trials. Engaging with industry peers can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss your previous experiences in managing quality assurance processes and how you've implemented improvements. Be ready to share specific examples that highlight your analytical skills and attention to detail.
✨Tip Number 4
Research WEP Clinical’s mission and values thoroughly. Understanding their commitment to innovation and patient care will allow you to align your responses 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 your CV highlights relevant experience in clinical quality assurance and compliance with GCP. Use specific examples from your past roles that demonstrate your ability to manage quality records, conduct audits, and implement corrective actions.
Craft a Compelling Cover Letter: In your cover letter, express your passion for clinical research and how your skills align with the role's objectives. Mention your experience with decentralized clinical trials and your strategic leadership qualities, as these are key attributes for the position.
Showcase Your Achievements: Include quantifiable achievements in your application. For instance, if you improved compliance rates or successfully led a quality assurance initiative, provide metrics to illustrate your impact. This will help you stand out as a results-driven candidate.
Proofread Your Application: Before submitting, thoroughly proofread your application for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial for a role focused on quality assurance.
How to prepare for a job interview at WEP Clinical Ltd
✨Understand GCP and Regulatory Requirements
Make sure you have a solid grasp of Good Clinical Practice (GCP) and other regulatory requirements like FDA and EMA guidelines. Be prepared to discuss how you've applied these principles in your previous roles, as this will demonstrate your expertise and readiness for the position.
✨Showcase Your Leadership Skills
As a Senior Clinical Quality Assurance Manager, you'll need to exhibit strong leadership qualities. Prepare examples of how you've led teams or projects in the past, particularly in quality assurance settings. Highlight your ability to make decisive and strategic decisions.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and adaptability. Think of specific instances where you've identified quality risks or implemented corrective actions, and be ready to explain your thought process and outcomes.
✨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 effectively communicated and collaborated with diverse teams, and how you handle conflicts or challenges in a professional setting.
