Amendment Implementation Specialist

This is a fully remote position, open to applicants in Bulgaria.

📋 Description

• Assist in implementing the amendment strategy across various regions.

• Partner with project teams for effective planning.

• Engage in discussions regarding financial coverage for amendments.

• Monitor and update actions related to amendments.

• Conduct calls to check on progress.

• Refresh compliance documentation as needed.

• Coordinate with regulatory teams concerning submissions.

• Compile study reports and oversee timelines.

• Recognize risks and devise contingency plans.

⛳️ Requirements

• A bachelor's degree or an equivalent qualification.

• Relevant prior experience in the field.

• Familiarity with audit processes and guidance documentation.

• Strong organizational abilities and meticulous attention to detail.

• Capability to analyze data and systems effectively.

• A strong customer-centric approach.

• Understanding of ICH GCP and the life cycle of clinical trials.

• Proficient in advanced English (both verbal and written).

• Skilled in MS Office and clinical trial database systems.

🏝️ Benefits

• Support for health and wellbeing.

• Opportunities for professional development.

• Flexible working arrangements.