Global Trial Acceleration Associate
Core
Managing and executing centralized activities for global clinical trials with an emphasis on clinical documentation, site activation, and regulatory submissions.
Role type
Clinical Trial Operations Associate
Builds
Global clinical trial documentation and site activation packages
Domain
Pharmaceutical / Clinical Research
Required skills
Clinical trial documentation management, Regulatory submission (IRB/IEC), Site activation, Stakeholder management, Quality control of start-up activities, Clinical systems management (CTMS, eTMF), Translation coordination, Document template creation, CSR distribution, ICF adaptation, Monitoring report review
Preferred skills
Field monitor experience (Clinical Research Associate), Therapeutic area expertise (Oncology, Cardiology, Hematology, Immunology), Veeva Vault experience
Technologies
CTMS, eTMF, Veeva Vault, SharePoint, MS Office
Responsibilities
Manage start-up documentation for global clinical trials, Submit investigators for debarment review, Handle country/site activation and checklist sign-off, Review and approve essential clinical documents, Coordinate certified translations of study materials, Review Site Monitoring Visit reports and manage escalations, Maintain clinical trial systems for document status tracking
Seniority
Mid-level, hands-on IC