Gcp Compliance Manager

GCP Compliance Manager, (EMEA)
100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine - imagine the impact you could have #GCO
The Good Clinical Practice (GCP) Compliance Manager (EMEA Hub) is accountable for the compliance oversight and control of regulated Global Clinical Organization activities focusing on EMEA Hub & Country level delivery including country trial level conduct as per country assignment. This role contributes to all compliance activities supporting the three pillars of GCP Compliance, issue management, audits & inspections as per country assignment and GCO self-strategy delivery.
Your key responsibilities, but not limited to;
- Management and day-to-day support provided in program/trial level quality issues, deviations and quality events management
- Coordination and support to program/trial delivery teams for audits and inspections based on trials’ selection and audit/inspection scope
- Delivery of the GCO self-assessment strategy related checks and controls
- Support cross-functions risk assessments if program/trial/country level in scope and contribute to the monitoring of relevant indicators/metrics/thresholds
- Contribute to the execution of the GCO GCP Compliance strategy under the leadership of the GCP Compliance Head (EMEA hub)
- Drive the compliance oversight and control of regulated GCO activities focusing on EMEA Hub & Country level delivery including country trial level conduct as per country assignment, working closely with the Hub & Country teams members, the relevant functions across GCO, involving and collaborating as required with GDD and the wider organization, such as Quality Assurance
- Be the single point of contact for EMEA Hub & Country team members as per country assignment for GCP Compliance

Desirable requirements:

- 8+ years industry experience specifically in clinical operations and clinical site management with a strong understanding of clinical research international standards and regulatory requirements from Health Authorities. Audits and inspections experience highly desirable.
- 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 mínimal guidance.
- Ability to make & communicate difficult decisions, associated with strong written and verbal communication skills.
- Self-awareness, willingness to further develop own strengths and explore opportunities for improvement.

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying Imagine what you could achieve here at Novartis
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Accessibility and accommodation

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

Desirable requirements:

- 8+ years industry experience specifically in clinical operations and clinical site management with a strong understanding of clinical research international standards and regulatory requirements from Health Authorities. Audits and inspections experience highly desirable.
- 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 contr