The role involves leading a cross-functional study team to ensure clinical study progress aligns with timelines, budget, and quality standards
Job Summary
The role involves leading a cross-functional study team to ensure clinical study progress aligns with timelines, budget, and quality standards.
Candidates must demonstrate extensive knowledge of clinical research regulatory requirements and the ability to manage outsourced studies through CRO partnerships.
The position requires ensuring all studies remain inspection-ready at all times according to ICH-GCP and company SOPs.
Matching Summary
The role involves leading a cross-functional study team to ensure clinical study progress aligns with timelines, budget, and quality standards.
Skills & Requirements
Must-have
7 years clinical R&D experience
2 years project management experience
ICH-GCP regulatory compliance knowledge
CRO oversight and management skills
Clinical Study Protocol development
Budget forecasting and management
Risk-based quality management
Nice-to-have
Mentoring less experienced colleagues
Leading process improvement projects
Strong conflict management abilities
Strategic critical thinking skills
Experience with non-drug projects
Key Requirements
University degree in medical or biological sciences
7 years relevant clinical experience in pharmaceutical R&D
2 years project management experience
Right to work in the country where the role is advertised
Work Rights
Must have right to work in the country/ies where the role is advertised