The role serves as the Single Point of Contact for assigned studies, ensuring adherence to SOPs and project timelines
Job Summary
The role serves as the Single Point of Contact for assigned studies, ensuring adherence to SOPs and project timelines.
Responsibilities include preparing regulatory documents, negotiating site contracts, and managing start-up activities according to applicable regulations.
Candidates must possess in-depth knowledge of clinical systems and the ability to apply GCP/ICH guidelines within a regulated environment.
Matching Summary
The role serves as the Single Point of Contact for assigned studies, ensuring adherence to SOPs and project timelines.
Skills & Requirements
Must-have
Bachelor's Degree in life sciences
3 years clinical research experience
Knowledge of GCP/ICH guidelines
Site regulatory document preparation
Contract and budget negotiation skills
Nice-to-have
Mentoring less experienced staff
Feasibility and site identification support
Bid defense and proposal assistance
Strong communication and organizational skills
Ability to work independently
Key Requirements
Bachelor's Degree in life sciences or related field
3 years' clinical research or relevant experience
Knowledge of local regulatory requirements and SOPs