Main point of contact (poc) for assigned protocols
This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations
Job Summary
This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations.
Leads local study teams to high performance by training in the protocol, collaborating with and supporting CRAs, and coordinating activities across different local country roles.
As a customer-facing role, this position will build business relationships and represent the company with investigators and medical centers.
Matching Summary
This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations.
Skills & Requirements
Must-have
End-to-end performance and project management
Compliance with ICH/GCP and country regulations
Main Point of Contact (POC) for assigned protocols
Leads local study teams to high performance
Creates and executes local risk management plan
Ensures compliance with CTMS, eTMF
Customer-facing role building business relationships
Nice-to-have
Mentorship capabilities
Fosters understanding of cultural diversity
High emotional intelligence
Strategic thinking and execution across projects
Diplomatic and empathic skills
Key Requirements
10+ years of experience in clinical research
5+ years of leading projects
Bachelor’s Degree in Science (or comparable)
Expertise in project and site management
Complete understanding of ICH GCP and regulatory environment
Strong scientific and clinical research knowledge
Proficiency in written and spoken English and local language