Leads/contributes to the preparation of delegated study documents and external service provider related documents
Job Summary
Leads/contributes to the preparation of delegated study documents and external service provider related documents.
Maintains and facilitates interactions with internal and external functions to ensure efficient study delivery.
Adheres to global clinical processes, procedural documents, and international guidelines such as ICH/GCP to ensure study is inspection ready at all times.
Matching Summary
Leads/contributes to the preparation of delegated study documents and external service provider related documents.
Skills & Requirements
Must-have
Vendor and external partner management
Clinical study document preparation
Cross-functional team collaboration
Risk and issue identification
ICH/GCP compliance
Investigational product supply management
Nice-to-have
Fostering an inclusive environment
Driving innovation and excellence
Shaping the future of clinical development
Nurturing talent and rewarding performance
Key Requirements
University degree in medical or biological sciences
At least 3 years of relevant experience
Experience in global study management
Knowledge of clinical development process
Excellent knowledge of ICH/GCP
Excellent communication and relationship building skills
Good project management skills
Advanced computer skills
Excellent verbal and written communication in English