Good Clinical Practice

vor 19 Stunden

Basel, Schweiz Novartis Vollzeit

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 GCP Compliance Head (EMEA hub) is accountable for the compliance oversight and control of regulated Global Clinical Operations (GCO) activities within scope all GCO managed clinical trials, GCO provided services and a focus on EMEA Hub & Country level delivery including country trial level conduct. This role provides leadership in the oversight and management of the three pillars of GCP Compliance as per focus above, issue management, audits & inspections as per program/trial/country’ selection and GCO self-strategy delivery; and in providing strong support to the GCO front-line dedicated to clinical site management, strengthening GCO Operational Excellence and enabling GCO to generate reliable scientific evidence.
- Your key responsibilities, but not limited to:
- Accountability for the compliance oversight and control of regulated GCO activities as per scope, focusing on EMEA Hub & Country level delivery including country trial level conduct
- Oversight of the GCP Compliance support provided to the front-line dedicated to clinical site management, strengthening Operational Excellence
- Oversight of Hub & Country level quality issues, deviations and quality events management
- Oversight of audits and inspections as per program/trial/country’ selection and scope
- Contribute to the self-assessment strategy development and accountable for its delivery
- GCO cross-functions risk assessments oversight and coordination if program/trial/country level in scope
- Lead a functional high-performance team of GCP Compliance managers with a strong focus on high quality, compliance and active risk management
- Contribute to developing a compliance culture within GCO, advocating the adherence to highest standards and ethical integrity

**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, with experience in leadership positions (including matrix leadership, stakeholders’ management, collaboration fostering to increase performance)
- Advanced understanding of drug development with experience in clinical operations and clinical site management, with an in-depth knowledge of clinical research international standards and regulatory requirements from Health Authorities. Audits and inspections experience highly desirable
- Strategic thinking and analytical skills; risk management and risk-based decision making knowledge and mindset
- Experienced in change management, intercultural experience, and ability to act in a complex and rapidly changing business environment
- Advanced degree in science, engineering or relevant discipline
- Project management/Risk Management
- Lean education/training, 6-Sigma

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**Division**
- Global Drug Development

**Business Unit**
- GDO GDD

**Country**
- Switzerland

**Work Location**
- Basel

**Company/Legal Entity**
- Novartis Pharma AG

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No

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