At a Glance
- Tasks: Guide clinical trial teams through complex compliance challenges and ensure adherence to Good Clinical Practice.
- Company: Join Novartis, a leading pharmaceutical company committed to innovation and quality.
- Benefits: Enjoy hybrid working, competitive salary, and opportunities for personal and professional growth.
- Other info: Collaborative environment with a strong focus on quality and continuous improvement.
- Why this job: Make a real impact in clinical trials while navigating exciting regulatory landscapes.
- Qualifications: Advanced degree in science or engineering and experience in clinical operations required.
The predicted salary is between 60000 - 75000 £ per year.
Hybrid working has an expectation of 12 days per month onsite. This role can also be provided on a Remote working basis, subject to eligibility criteria. Eligibility for remote work can be discussed at interview stage.
Location: Westworks, London, UK. Other Locations: Dublin, Ireland. Please apply to the Dublin advertisement for this location. This role is based in London, UK. Novartis is unable to offer relocation support; please only apply if you are accessible. Novartis is unable to sponsor Visas for this location.
Step into a role where your expertise helps Clinical Trial Teams navigate some of their most complex and high-risk decisions. As a GCP Compliance Manager – Clinical Programs & Trials, you will operate as a trusted partner embedded within the clinical trial environment, working across a portfolio of studies to provide expert guidance on Good Clinical Practice and support teams staying in compliance. You will support teams in solving complex scenarios which require careful risk‑assessment — translating technical requirements into clear, actionable insights that enable informed decision‑making.
Key Responsibilities
- Provide compliance oversight for clinical programs and trials, ensuring adherence to Good Clinical Practice standards
- Act as primary compliance partner to Clinical Trial Teams, enabling decision‑making on complex regulatory scenarios
- Lead cross‑functional discussions and resolution of quality issues using structured investigation and root cause analysis
- Translate complex regulatory requirements into clear, actionable guidance for cross‑functional clinical stakeholders
- Coordinate inspection readiness activities, including preparation and inspection management, in addition to subsequent CAPA management
- Monitor key indicators and trends to detect early signals, and support proactive mitigation strategies
- Deliver self‑assessment checks and controls, sharing insights to strengthen compliance and continuous improvement
- Collaborate across functions, including Quality Assurance and Development, to ensure aligned and effective compliance practices
- Support quality assessments of programs and trials and enable informed, risk‑based decision‑making
- Champion a strong culture of quality, data integrity, and accountability across Global Clinical Operations and beyond
Essential Requirements
- Advanced degree in science, engineering, or related discipline
- Significant experience in clinical operations and clinical trial management within a pharmaceutical or healthcare environment
- Strong knowledge of Good Clinical Practice standards and global regulatory requirements
- Proven ability to investigate complex issues, perform root cause analysis, and develop effective corrective actions
- Excellent communication skills with ability to translate technical compliance concepts into clear, practical guidance
- Strong problem‑solving mindset with curiosity and ability to navigate ambiguity and regulatory trade‑offs
- Demonstrated ability to work effectively in cross‑functional, matrixed teams and influence diverse stakeholders
- Ability to work independently, manage multiple trials simultaneously, and prioritise across competing demands
Desirable Requirements
- Experience supporting audits and inspections, including preparation and interaction with health authority inspections
- Openness to adopting and experimenting with artificial intelligence and new technologies to optimize ways of working
Learn about all the ways we’ll help you thrive personally and professionally.
GCP Compliance Manager - Clinical Programs & Trials employer: Novartis UK
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the heart of London. Our commitment to employee growth is evident through continuous learning opportunities and a supportive environment that encourages professional development. With a focus on quality and compliance in clinical trials, we empower our teams to make impactful decisions while enjoying the flexibility of hybrid working arrangements.
StudySmarter Expert Advice🤫
We think this is how you could land GCP Compliance Manager - Clinical Programs & Trials
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Novartis UK looking for candidates who are engaged and informed.
We think you need these skills to ace GCP Compliance Manager - Clinical Programs & Trials
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Novartis UK. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Novartis UK
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Novartis UK’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
