Архив. Compliance Process, Training & Systems (CPTS advisor)

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