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- Tasks: Lead quality assurance for clinical trials, ensuring compliance and supporting the Clinical Affairs team.
- Company: Join a leading organisation innovating in molecular data analysis for diagnostics.
- Benefits: Enjoy a competitive salary, bonus, and remote work flexibility with occasional travel.
- Why this job: Be part of a global team making a real impact in healthcare through cutting-edge technology.
- Qualifications: Degree-level qualification and 5 years' experience in a GCP environment required.
- Other info: This role is maternity cover; candidates must have the right to work in the UK.
The predicted salary is between 42000 - 58000 £ per year.
Job Type: 12 months fixed-term contract, Maternity cover
Location: Remote UK-based with occasional travel to the North West, England
Remuneration: £50,000 + 10% Bonus
Cpl Life Sciences is partnering with a leading organisation that uses technologies to help customers extract, analyze, and interpret molecular data from samples containing DNA, RNA, and proteins.
Due to maternity leave, we are looking for an experienced candidate to take responsibility for quality and compliance oversight of the activities performed by the Clinical Affairs team. The function supports the testing and registration of diagnostic tests/instruments covering a diverse portfolio of indications. The scope of the trials is global and includes multi-centre trials managed out of several different locations.
Key responsibilities:- As a senior member of the Clinical QA team, take responsibility for overseeing division of workload, advising, and supporting the team as required
- Work with members of the Clinical Affairs team to ensure compliance during trial activities e.g. closure of deviations, complaints etc.
- Review Clinical relevant documentation throughout the clinical trial
- Coordinate and provide input to reporting of Clinical Affairs compliance KPIs
- Participate in the Internal Audit program
- Review Clinical Affairs SOPs
- Degree-level qualification (or equivalent experience)
- Minimum 5 years’ experience in a GCP environment with demonstrable, working knowledge of GCP practices
- Desirable: working knowledge of IVD or medical device regulations
- Qualified Auditor
- Experience in performing as a Subject Matter Expert in regulatory inspections and other formal audits
- Willingness to travel internationally up to 10%
- A strong team player with excellent communication and interpersonal skills who puts value into working cross functionally with multinational/cultural teams and individuals
Please note this role does not offer sponsorship and will need candidates to hold the full right to work in the UK and be BASED in the UK.
For more information please contact me at lucy.kirkaldy@cpl.com
Clinical Quality Assurance Manager - FTC employer: LinkedIn
Contact Detail:
LinkedIn Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Quality Assurance Manager - FTC
✨Tip Number 1
Familiarise yourself with the latest GCP guidelines and IVD regulations. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the Clinical QA field, especially those who have experience with IVDs or medical devices. Engaging in discussions can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences where you successfully managed compliance issues or led audits. This will showcase your expertise and problem-solving skills during the interview.
✨Tip Number 4
Research the company’s recent projects and initiatives in the molecular data space. Being knowledgeable about their work will allow you to tailor your responses and show genuine interest in their mission.
We think you need these skills to ace Clinical Quality Assurance Manager - FTC
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in GCP environments and any relevant qualifications. Emphasise your knowledge of IVD or medical device regulations, as well as your auditing experience.
Craft a Compelling Cover Letter: In your cover letter, explain why you are the perfect fit for the Clinical Quality Assurance Manager role. Mention your experience with clinical trials and your ability to work cross-functionally with diverse teams.
Highlight Key Skills: Focus on key skills such as compliance oversight, team leadership, and communication. Provide specific examples of how you've successfully managed quality assurance in previous roles.
Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for this role.
How to prepare for a job interview at LinkedIn
✨Showcase Your GCP Knowledge
Make sure to highlight your experience in Good Clinical Practice (GCP) during the interview. Be prepared to discuss specific examples of how you've ensured compliance in previous roles, as this is crucial for the Clinical Quality Assurance Manager position.
✨Demonstrate Team Leadership Skills
As a senior member of the Clinical QA team, you'll need to oversee and support your colleagues. Share instances where you've successfully managed a team or project, focusing on how you divided workloads and provided guidance.
✨Prepare for Regulatory Questions
Expect questions related to IVD and medical device regulations. Brush up on relevant regulations and be ready to discuss your experience with regulatory inspections and audits, as this will show your expertise in the field.
✨Emphasise Communication Skills
Since the role requires working cross-functionally with diverse teams, be sure to convey your strong communication and interpersonal skills. Share examples of how you've effectively collaborated with different stakeholders in past projects.
