Summary
ROLE TYPE: Hybrid Working, #LI-Hybrid
Relocation is not offered for this role
The GCP Compliance Manager (Program & Study) is accountable for the compliance oversight and control of regulated GCO activities focusing on program/trial level delivery as per program(s)/trial(s) assignment. This role contributes to all compliance activities supporting the three pillars of GCP Compliance, issue management, audits & inspections as per program/trials’ selection and GCO self-strategy delivery.
The GCP Compliance Manager (Program & Study) is the single point of contact for Clinical Trial Teams for GCP Compliance, providing day-to-day support and ongoing quality oversight. This role promotes a product quality culture within GCO supporting the GCP Compliance Head (Program & Study), focusing on quality and compliance being increased and sustained and on active risk management.
About the Role
Major accountabilities:
- Accountable for the compliance oversight and control of regulated GCO activities focusing onprogram/trial level delivery as per program(s)/trial(s) assignment.
- Single point of contact for Clinical Trial Teams for GCP Compliance.
- As per focus area and assignment, management and day-to-day support provided inprogram/trial level quality issues, deviations and quality management.
- Coordination and support to Clinical Trial Teams for audits and inspections based onprogram/trial/country selection and scope.
- Delivery of the GCO self-assessment strategy related checks and controls.
- Support cross-functions risk assessments if programs or trials identified and contribute to themonitoring of relevant indicators/metrics/thresholds
Education Requirements: Advanced degree in science, engineering or relevant discipline.
Work Experience:
- 8+ years industry experience specifically in clinicaloperations and trial management with a strongunderstanding of clinical research international standardsand regulatory requirements from Health Authorities.Audits and inspections experience highly desirable.
- Organizational and analytical skills associated with anaptitude in quality management and continuousimprovement.
- Critical thinking ability and risk management and risk based knowledge and mindset.
- Ability in partnering with a proactive and solution-orientedmindset.
- Strong skills to facilitate/optimize contribution of teammembers as individuals and members of a cohesive team.
- Ability to work effectively in a matrix cross-functionalenvironment.
- Strong capacity for working independently with minimalguidance.
- Ability to make & communicate difficult decisions,associated with strong written and verbal communicationskills.
- Self-awareness, willingness to further develop ownstrengths and explore opportunities for improvement
Languages :
- English.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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? https://www.novartis.com/about/strategy/people-and-culture
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
