This is a permanent, full-time role at Roche, Global Healthcare Company for an experienced in clinical trials individual with expertise and strong mindset in quality and compliance areas
Main Qualification
Ø Bachelor degree, preferably in a medical/science-related field;
Ø Experience working in clinical operations management
Ø Demonstrating knowledge and understanding of clinical trials;
Ø Effective leadership, influencing skills and teamwork supporting an environment of mutual respect, embracing change, innovation and accountability
Ø Ability to deliver impactful and effective solutions and outputs
Ø A clear understanding of GCP and compliance process, activities and issues and the ability to develop, manage, and improve compliance activities
Ø Expert knowledge of ICH GCP and local regulatory requirements
Ø Skilled in setting milestones, driving toward and monitoring results
Ø Self-motivated, attentive to detail and achievement driven with ability to work independently.
Ø Strong written and verbal communication skills (in Ukrainian, Russian and English)
Ø Readiness to travel domestically and abroad, if necessary;
Main responsibilities:
• A first line support for local clinical operations towards GCP compliance, process, systems and training matters
• Ensures clinical trials compliance to local laws and applicable regulations
• Ensures GCP Inspection Readiness status in alignment with global and regional plans/goals
• Conducts QA&QC activities implementing risk-management approach in local GCP area
• Shares local GCP compliance insights to identify trends and risks to implement effective actions to mitigate risks
• Provides support for audits and inspections related to clinical operations, country and investigator site management
• Ensures CAPAs from audits and inspection reports for GCP related findings are effectively implemented are shared
• Inputs into local/sub-regional CPTS strategy and locally delivers CPTS tactics
• Manages ongoing changes to regulations, guidelines, ICH-GCP standards and global processes
• Carries out alignment activities between global and local procedural documents
• Develops and maintains local procedural documents and/or business processes for local clinical operations
• Delivers fit for purpose training programs and effective consultancy/SME to support local clinical operations to the greater extent
• Partners with clinical operations teams to ensure their adherence to key processes, systems and initiatives
• Acts as a local or regional subject matter expert (SPOC) for a specific focus area
• Pro-actively identifies areas for improvement, proposes, participates and/or leads improvement initiatives
• Provides oversight of the Functional Service Provider being responsible for proactive identifying, managing and escalating risks and issues related to GCP compliance, process, system and training
• Participates as an active member of the Local Medical Compliance governance model representing the GCP pillar
• Actively participates in regional CPTS team meetings and works in close collaboration with regional CPTS team