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- Tasks: Lead quality management initiatives and ensure compliance in clinical research.
- Company: Join IQVIA, a global leader in clinical research and healthcare intelligence.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact on patient outcomes while working with innovative medical treatments.
- Qualifications: Bachelor's degree and knowledge of clinical research regulations required.
- Other info: Dynamic team environment with a focus on integrity and innovation.
The predicted salary is between 36000 - 60000 £ per year.
This Quality Manager role is assigned to a designated sponsor. The purpose of this role is to work together with global Quality Management, Site Management, and other stakeholders in a joint effort to define the global Quality Plan, carry out, and adopt the plan according to the specific needs defined by the scope of assignment, to assist staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines.
This role coordinates and oversees staff within the scope of the assignment, provides advice, and supports staff and other relevant key stakeholders with regard to quality control, risk management, and corrective/preventive actions.
Essential Functions- Adopt and implement the global Quality Management Plan within the scope of the assignment, including planning and executing the Quality Management activities, risk identification and assessment through data review and quality control processes, providing support in risk mitigation, planning corrective/preventive actions, and guidance for improvement.
- Cooperate closely with the relevant business and other stakeholders, supporting maintaining focus on quality in project delivery.
- Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management Plan and Risk Management Program, monitor the implementation and delivery.
- Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.
- Work in close cooperation with teams to manage non-compliance, quality issues, assist in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs).
- Inform Quality Management, assigned business line, and Quality Assurance of quality issues according to SOPs.
- Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
- May provide assistance during audits and regulatory inspections to the teams to the extent agreed with Quality Management and as required by the applicable SOPs.
- Act as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences.
- Prepare periodic reports to Head(s) of business lines on quality related matters, risk assessments and specific quality improvement initiatives.
- Manage staff in accordance with organization’s policies and applicable regulations, including planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems.
- Upon agreement with the line manager: Perform any other reasonable tasks as required by the role.
- Bachelor's Degree or equivalent qualification.
- Equivalent combination of education, training, and experience.
- Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes.
- Knowledge of National and International Regulations and Drug Development processes.
- Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.
- Knowledge of IQVIA corporate standards and SOPs.
- Good organizational, interpersonal and communication skills.
- Good judgement and decision-making skills.
- Strong influencing and negotiation skills.
- Strong computer skills including Microsoft Office applications.
- Excellent problem solving skills.
- Ability to travel within the region/country.
- Ability to lead and motivate a clinical team.
- Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.
- Fluent in English.
Clinical FSP Quality Manager in England employer: IQVIA LLC
Contact Detail:
IQVIA LLC Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical FSP Quality Manager in England
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. The more people you know, the better your chances of landing that Clinical FSP Quality Manager role.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their quality management processes and be ready to discuss how your experience aligns with their needs. Show them you’re not just a fit on paper but also a great cultural match!
✨Tip Number 3
Practice your answers to common interview questions, especially those related to quality management and compliance. Use the STAR method (Situation, Task, Action, Result) to structure your responses and highlight your achievements effectively.
✨Tip Number 4
Don’t forget to follow up after your interviews! A simple thank-you email can go a long way in keeping you top of mind. It shows your enthusiasm for the role and reinforces your professionalism.
We think you need these skills to ace Clinical FSP Quality Manager in England
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Clinical FSP Quality Manager role. Highlight relevant experience and skills that match the job description, especially around quality management and compliance.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of how you've successfully managed quality in previous positions and how you can bring that expertise to our team.
Be Honest and Clear: We value honesty in our hiring process. Ensure all information you provide is truthful and clear. Misrepresentations can lead to disqualification, so keep it straightforward and professional.
Apply Through Our Website: For the best chance of success, apply directly through our website. This ensures your application goes straight to the right people and helps us get to know you better!
How to prepare for a job interview at IQVIA LLC
✨Know Your Quality Standards
Familiarise yourself with the International Conference on Harmonization (ICH) guidelines and Good Clinical Practice (GCP). Be ready to discuss how you’ve applied these standards in your previous roles, as this will show your understanding of the quality management processes relevant to the position.
✨Showcase Your Leadership Skills
As a Clinical FSP Quality Manager, you'll need to lead and motivate teams. Prepare examples of how you've successfully managed teams in the past, focusing on your ability to resolve conflicts, guide professional development, and enhance team effectiveness.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and decision-making abilities. Think of specific situations where you identified risks or non-compliance issues and how you implemented corrective actions. This will demonstrate your proactive approach to quality management.
✨Communicate Clearly and Confidently
Strong communication skills are essential for this role. Practice articulating your thoughts clearly, especially when discussing complex topics like regulatory requirements or quality improvement initiatives. This will help you convey your expertise effectively during the interview.
