Site Activation Specialist, Informed Consent Form LEAD
Core
Oversee the development, review, and rollout of Informed Consent Forms (ICF) across multiple countries and studies, ensuring accuracy, compliance, and timely delivery.
Role type
Senior Site Activation Specialist (ICF)
Builds
Master and country-level Informed Consent Forms for clinical studies
Domain
Clinical Research / Life Sciences
Required skills
ICF development and review, protocol alignment, regulatory compliance (ICH/GCP), project coordination, mentorship, escalation management
Preferred skills
Knowledge of regulatory guidelines, multi-country coordination
Technologies
None stated
Responsibilities
Lead and support ICF development (master & country level), Review ICFs for accuracy and protocol alignment, Coordinate updates based on regulatory or guideline changes, Track approvals and ensure timely execution of ICF documents, Collaborate with sponsors and internal teams on project timelines, Support and mentor country CSA specialists, Act as a point of escalation for ICF‑related matters
Seniority
Mid-Senior, hands-on IC
