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- Tasks: Lead quality management efforts in clinical research and ensure compliance with global standards.
- Company: Join IQVIA, a 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 collaboration 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, monitoring 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 employer: IQVIA LLC
Contact Detail:
IQVIA LLC Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical FSP Quality Manager
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a job that’s perfect for you.
✨Tip Number 2
Prepare for interviews by researching the company and its values. Understand their approach to quality management and be ready to discuss how your experience aligns with their goals. This shows you’re genuinely interested and can hit the ground running.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to GCP compliance and risk management. The more comfortable you are with your answers, the more confident you'll appear during the interview.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re proactive and serious about joining our team.
We think you need these skills to ace Clinical FSP Quality Manager
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Clinical FSP Quality Manager role. Highlight your relevant experience with quality management, GCP compliance, and any specific projects that align with the job description.
Showcase Your Skills: Don’t forget to emphasise your organisational, communication, and problem-solving skills. These are key for this role, so give examples of how you've used them in past positions to drive quality improvements.
Be Honest and Professional: We value integrity, so ensure all the information you provide is truthful and complete. Any misrepresentation can lead to disqualification, so keep it real and professional throughout your application.
Apply Through Our Website: For the best chance of success, make sure to submit your application through our website. This way, we can easily track your application and get back to you quicker!
How to prepare for a job interview at IQVIA LLC
✨Know Your Quality Management Basics
Make sure you brush up on your knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Being able to discuss these concepts confidently will show that you're well-prepared and understand the core responsibilities of a Clinical FSP Quality Manager.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific quality control issues or risk management scenarios. Think of examples from your past experience where you successfully implemented corrective actions or improved compliance, and be ready to share those stories.
✨Showcase Your Leadership Skills
As this role involves managing staff and guiding teams, be prepared to discuss your leadership style. Highlight experiences where you've motivated a team or resolved conflicts, as this will demonstrate your ability to lead effectively in a clinical environment.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions ready about the company's quality management processes or how they measure success in this role. This shows your genuine interest in the position and helps you assess if it's the right fit for you.
