One of our top clients, a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, biologic therapies, consumer care and animal health products now seeks to employ a Clinical Research Manager.

The incumbent will be accountable for the performance for assigned protocols in the country in compliance with ICH/GCP and RSA regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. The incumbent will also be responsible for clinical trial education to sites, and act as the country POC for programmatically outsourced trials for assigned protocols.

Minimum Requirements:
Bachelor of Science in a scientific discipline
Minimum of 10 years experience in a clinical CRA role (GCP) in a CRO or pharmaceutical company
Preference will go to candidates with prior Quality Assurance experience
Minimum 5 years of supervisory/management experience
Advanced knowledge of ICH GCP content and application, ICH E series Guidelines, Good Clinical Laboratory Practices and 21CFR Part 11
Demonstrated experience in developing, implementing and managing Clinical Program Auditing
Proven ability to identify CAPA and close Non-compliance
Solid understanding of scientific and medical concepts within a clinical program
Must be able to travel
Detail-oriented with strong verbal and written communications skills
Ability to multi-task and be a self-starter
Salary is highly negotiable