At a Glance
- Tasks: Guide clinical teams through complex compliance challenges in clinical trials.
- Company: Join Novartis, a leader in healthcare and an inclusive employer.
- Benefits: Hybrid working, competitive salary, and opportunities for personal growth.
- Other info: Collaborative environment with a focus on innovation and quality.
- Why this job: Make a real impact on patient lives while navigating exciting challenges.
- Qualifications: Advanced degree and experience in clinical operations required.
The predicted salary is between 60000 - 80000 £ per year.
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
For Hybrid working there is 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 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.
About the Role:
- Acting as a key point of contact across study leaders, vendor managers, and cross-functional stakeholders, you will enable issue resolution, strengthen inspection readiness, and ensure trials are delivered to the highest standards of quality and compliance.
- This is a role for a curious, solutions-oriented professional who thrives on investigation, collaboration, and influencing outcomes in a fast-paced, global clinical landscape.
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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.
GCP Compliance Manager - Clinical Programs & Trials employer: Novartis
At Novartis, we pride ourselves on being an inclusive employer that fosters a collaborative and supportive work culture. As a GCP Compliance Manager in our London office, you will have the opportunity to engage with diverse teams, drive meaningful change in clinical trials, and benefit from professional growth opportunities in a dynamic environment. With a commitment to quality and innovation, we empower our employees to thrive both personally and professionally, making Novartis an exceptional place to advance your career.
StudySmarter Expert Advice🤫
We think this is how you could land GCP Compliance Manager - Clinical Programs & Trials
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at Novartis or similar companies. A friendly chat can open doors and give you insights that might just help you land that GCP Compliance Manager role.
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of Good Clinical Practice standards. Be ready to discuss how you've navigated complex regulatory scenarios in the past. We want to see your problem-solving skills in action!
✨Tip Number 3
Show off your collaboration skills! Think of examples where you've worked with cross-functional teams to resolve issues. Highlighting your ability to influence diverse stakeholders will make you stand out as a candidate.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you're serious about joining the Novartis team and contributing to their mission.
We think you need these skills to ace GCP Compliance Manager - Clinical Programs & Trials
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the GCP Compliance Manager role. Highlight your experience in clinical operations and compliance, and don’t forget to mention any relevant qualifications or certifications that align with the job description.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Share specific examples of how you've navigated complex regulatory scenarios and contributed to compliance in previous roles.
Showcase Your Communication Skills:Since this role requires excellent communication skills, make sure to demonstrate this in your application. Use clear and concise language, and consider including examples of how you've effectively communicated complex concepts to diverse stakeholders.
Apply Through Our Website:We encourage you to apply through our website for the best chance of success. It’s straightforward and ensures your application goes directly to the right team. Plus, you’ll get to explore more about our culture and values while you’re at it!
How to prepare for a job interview at Novartis
✨Know Your GCP Inside Out
Make sure you brush up on Good Clinical Practice (GCP) standards and global regulatory requirements. Be ready to discuss how you've applied these in past roles, as this will show your expertise and readiness for the GCP Compliance Manager position.
✨Prepare for Scenario-Based Questions
Expect questions that require you to solve complex regulatory scenarios. Think of examples from your experience where you had to perform root cause analysis or lead cross-functional discussions. This will demonstrate your problem-solving mindset and ability to navigate ambiguity.
✨Showcase Your Communication Skills
Since you'll be translating technical compliance concepts into clear guidance, practice explaining complex ideas simply. You might even want to prepare a few examples of how you've successfully communicated with diverse stakeholders in the past.
✨Emphasise Collaboration and Influence
This role requires working effectively in cross-functional teams. Be ready to share specific instances where you've influenced outcomes or resolved quality issues through collaboration. Highlighting your teamwork skills will resonate well with the interviewers.
