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- Tasks: Lead clinical quality assurance and ensure top-notch standards in pharmaceutical innovation.
- Company: Proclinical, a leading life sciences recruiter with a global reach.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact on patient safety and clinical trial excellence.
- Qualifications: Bachelor's degree and experience in Clinical Quality Assurance required.
- Other info: Dynamic role with travel opportunities and a focus on continuous improvement.
The predicted salary is between 43200 - 72000 £ per year.
Lead the charge in safeguarding clinical excellence-step into a pivotal Senior Director QA role where your expertise ensures the highest standards in pharmaceutical innovation. Proclinical is seeking an Associate Director of Clinical Quality Assurance to oversee GCP activities, lead audits and inspection management, and ensure the high‑quality execution of clinical trials. This role involves collaborating with internal and external stakeholders, providing GCP QA support, and contributing to the continuous improvement of clinical development processes.
Responsibilities
- Represent Clinical Quality Assurance (CQA) in cross‑functional team meetings.
- Support the training and development of CQA colleagues.
- Provide proactive GCP QA support to ensure patient safety, data integrity, and operational excellence.
- Conduct various audits, including Clinical Investigator Site Audits, GCP Document Audits, Clinical Study Reports, Trial Master Files, internal Process Audits, and Vendor‑System audits.
- Act as the CQA Lead for clinical studies, managing audit plans and reports.
- Facilitate quality improvement by communicating audit results, CAPAs, and providing GCP guidance to clinical teams.
- Manage health authority inspection preparation and provide leadership during inspections.
- Review and provide input on clinical documentation such as protocols, study reports, IBs, and ICFs.
- Compile and analyze audit metrics to identify trends and communicate findings to business groups.
- Conduct GCP training sessions for internal teams.
Key Skills and Requirements
- Bachelor's degree in a relevant discipline.
- Experience in Clinical Quality Assurance within the pharmaceutical industry.
- Knowledge of health authority inspection management.
- Ability to develop SOPs and training materials.
- Proficiency in conducting routine, complex, and for‑cause GCP audits.
- Strong interpersonal and professional communication skills.
- Effective time management and ability to handle competing priorities.
- Familiarity with US, EU, and international regulatory standards for clinical trials.
- Attention to detail, analytical thinking, and strong report‑writing skills.
- Ability to navigate challenging situations diplomatically and collaboratively.
- Proficiency in English (spoken and written).
- Willingness to travel approximately 25%.
Associate Director, Clinical QA (GCP) (Hybrid) employer: Proclinical Group
Contact Detail:
Proclinical Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Clinical QA (GCP) (Hybrid)
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry and let them know you're on the hunt for an Associate Director role. You never know who might have the inside scoop on openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your GCP knowledge and audit experience. Be ready to share specific examples of how you've ensured patient safety and data integrity in past roles. This will show that you’re not just a fit on paper, but also in practice!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After interviews, send a quick thank-you email to express your appreciation and reiterate your enthusiasm for the role. It keeps you fresh in their minds and shows your professionalism.
✨Tip Number 4
Apply through our website for the best chance at landing that dream job! We make it easy for you to showcase your skills and experience directly to hiring managers. Plus, it’s a great way to stay updated on new opportunities tailored to your expertise.
We think you need these skills to ace Associate Director, Clinical QA (GCP) (Hybrid)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Associate Director role. Highlight your experience in Clinical Quality Assurance and any relevant audits you've conducted. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about GCP and how you can contribute to safeguarding clinical excellence at StudySmarter. Keep it engaging and personal.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use specific examples of how you've improved processes or led successful audits. We love seeing quantifiable results that demonstrate your impact.
Apply Through Our Website: We encourage you to apply directly through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates!
How to prepare for a job interview at Proclinical Group
✨Know Your GCP Inside Out
Make sure you brush up on Good Clinical Practice (GCP) guidelines and any recent updates. Being able to discuss these confidently will show that you're not just familiar with the standards but are also committed to maintaining them in your work.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific situations, like managing an audit or dealing with a health authority inspection. Think of examples from your past experience where you successfully navigated similar challenges and be ready to share those stories.
✨Showcase Your Leadership Skills
As this role involves leading audits and managing teams, be prepared to discuss your leadership style. Highlight experiences where you've trained colleagues or led cross-functional teams, demonstrating your ability to inspire and guide others in achieving clinical excellence.
✨Familiarise Yourself with the Company Culture
Research Proclinical and understand their values and mission. Tailor your responses to reflect how your personal values align with theirs, and be ready to discuss how you can contribute to their goals in clinical quality assurance.
