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- Tasks: Ensure top-notch quality in clinical trials and lead compliance efforts.
- Company: Proclinical, a leading life sciences recruiter with a global reach.
- Benefits: Flexible remote work, competitive salary, and opportunities for professional growth.
- Why this job: Make a real difference in oncology outcomes while working from home.
- Qualifications: Strong background in clinical QA, GCP compliance, and excellent problem-solving skills.
- Other info: Join a dynamic team focused on innovation and quality in clinical research.
The predicted salary is between 36000 - 60000 £ per year.
Are you driven by improving oncology outcomes and looking for a role where quality truly matters? Looking for a flexible position where you can work from the comfort of your home? Proclinical is seeking an Associate Director of Clinical Quality Assurance to support clinical programs and trials with a focus on Good Clinical Practice (GCP) compliance. This role involves ensuring the highest quality standards in clinical trial documentation, addressing quality issues, and preparing for regulatory inspections.
Responsibilities
- Review key clinical trial documentation, including protocols, investigator brochures, informed consent forms, and trial master files.
- Lead assessments and investigations of quality issues, driving root cause analysis, remediation, and timely resolution.
- Facilitate reviews of potential serious breaches and urgent safety measures for assigned clinical programs.
- Coordinate GCP-GVP vendor audits, manage audit programs, and ensure proper execution and closure of audits.
- Oversee quality management with functional lines and vendors, including leading Quality Oversight Committee meetings.
- Collaborate on implementing risk-based quality management (RBQM) for studies, focusing on critical data identification and reporting.
- Lead pre-approval and routine regulatory inspection readiness activities, including strategy development and program management.
- Provide guidance and training on compliance issues, leveraging expertise in GCP and industry best practices.
- Support the development, implementation, and maintenance of GCP standard operating procedures (SOPs).
Key Skills and Requirements
- Strong background in clinical quality assurance and GCP compliance.
- Experience in reviewing and managing clinical trial documentation.
- Knowledge of regulatory requirements and inspection readiness processes.
- Ability to lead audits and manage CAPAs effectively.
- Familiarity with oncology clinical trials is preferred.
- Excellent problem-solving skills and adaptability.
- Strong collaboration and communication abilities.
Associate Director, Clinical QA (GCP) employer: Proclinical Staffing
Contact Detail:
Proclinical Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Clinical QA (GCP)
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical QA field, especially those who have experience with GCP compliance. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of oncology trials and GCP standards. We recommend creating a list of common interview questions and practising your responses to show off your expertise.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you email to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the role.
✨Tip Number 4
Apply directly through our website for the best chance at landing that Associate Director role. We make it easy for you to showcase your skills and experience, so don’t miss out!
We think you need these skills to ace Associate Director, Clinical QA (GCP)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Associate Director, Clinical QA role. Highlight your experience in GCP compliance and clinical trial documentation. We want to see how your background aligns 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 improving oncology outcomes and how your skills can contribute to our mission. Keep it engaging and relevant to the role.
Showcase Your Problem-Solving Skills: In your application, don’t forget to mention specific examples of how you've tackled quality issues in the past. We love seeing candidates who can demonstrate their problem-solving abilities and adaptability!
Apply Through Our Website: We encourage you to apply directly through our website for a smoother process. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity!
How to prepare for a job interview at Proclinical Staffing
✨Know Your GCP Inside Out
Make sure you brush up on Good Clinical Practice (GCP) guidelines before the interview. Be ready to discuss how you've applied these principles in your previous roles, especially in oncology trials. This will show that you’re not just familiar with the standards but can also implement them effectively.
✨Prepare for Quality Issue Scenarios
Think of specific examples where you've identified and resolved quality issues in clinical trials. Be prepared to walk through your thought process during these situations, including root cause analysis and remediation strategies. This will demonstrate your problem-solving skills and adaptability.
✨Familiarise Yourself with Regulatory Requirements
Since this role involves preparing for regulatory inspections, it’s crucial to know the latest regulatory requirements. Research common inspection findings and be ready to discuss how you would ensure compliance and readiness in your previous experiences.
✨Showcase Your Collaboration Skills
This position requires strong collaboration with various teams and vendors. Prepare to share examples of how you've successfully worked with cross-functional teams, led meetings, or facilitated audits. Highlighting your communication abilities will set you apart as a candidate who can lead and inspire others.
