At a Glance
- Tasks: Oversee compliance in global clinical operations and manage audits and inspections.
- Company: Leading organisation in clinical research with a commitment to quality and innovation.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Inclusive workplace that values diverse perspectives and experiences.
- Why this job: Join a dynamic team making a real difference in clinical research compliance.
- Qualifications: 8+ years in clinical operations with strong analytical and communication skills.
The predicted salary is between 36000 - 60000 £ per year.
GCP Compliance Manager - Global Clinical Operations
The Good Clinical Practice (GCP) Compliance Manager for Global Clinical Operations (GCO) is accountable for the compliance oversight and control of regulated GCO activities focusing on GCO wide activities potentially having a high impact on GCO ability to deliver as per objectives, as per assignment.
This role contributes to all compliance activities supporting the three pillars of GCP Compliance, issue management, audits & inspections particularly system/process audits and global inspections supporting authorizations and GCO self-strategy delivery.
The GCP Compliance Manager (GCO) provides Good Practice (GxP) expertise and may be referred in providing GCP Compliance support to other functions, compliance, process, training and risk groups.
Major accountabilities:
- Accountability for the GCP compliance oversight and control of regulated GCO activities focusing on GCO wide activities potentially having a high impact on GCO ability to deliver as per objectives, as per assignment.
- Provide GxP expertise and may be referred in providing GCP Compliance support to other functions, compliance, process, training and risk groups.
- Management of GCO wide systemic quality issues, deviations and quality events management.
- Management of the GCO GCP audits and GCP inspections landscape and coordination of system/process audits & global inspections supporting authorizations including inspection readiness.
- Delivery of the GCO self-assessment strategy related checks and controls.
- Coordination of GCO cross-functions risk assessments as per scope and as assigned.
- Manage GCO wide systemic quality issues, deviations and quality events as per assignment, providing expertise in investigation, Root Cause Analysis (RCA) and Corrective And Preventive Action (CAPA) development.
Minimum Requirements:
- 8+ years industry experience specifically in clinical operations with an advanced knowledge of clinical research international standards and regulatory requirements from Health Authorities.
- Organizational and analytical skills associated with an aptitude in quality management and continuous improvement.
- Critical thinking ability and risk management and risk based knowledge and mindset.
- Ability in partnering with a proactive and solution-oriented mindset.
- Strong skills to facilitate/optimize contribution of team members as individuals and members of a cohesive team.
- Ability to work effectively in a matrix cross-functional environment.
- Strong capacity for working independently with minimal guidance.
- Ability to make & communicate difficult decisions, associated with strong written and verbal communication skills.
Education:
- Minimum: Advanced degree in science, engineering or relevant discipline.
Languages:
- English.
We are an equal opportunities employer and welcome applications from all qualified candidates.
GCP Compliance Manager - Global Clinical Operations in City of London employer: Novartis
As a GCP Compliance Manager in Global Clinical Operations, you will join a dynamic team dedicated to ensuring the highest standards of compliance in clinical research. Our company fosters a collaborative work culture that values continuous improvement and professional growth, offering extensive training and development opportunities. Located in a vibrant area, we provide a supportive environment where your expertise will directly impact our mission to deliver quality outcomes in clinical operations.
StudySmarter Expert Advice🤫
We think this is how you could land GCP Compliance Manager - Global Clinical Operations in City of London
✨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 looking for candidates who are engaged and informed.
We think you need these skills to ace GCP Compliance Manager - Global Clinical Operations in City of London
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. 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
✨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’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
