Global Trial Acceleration Associate
Core
Managing and executing centralized clinical trial activities with an emphasis on clinical documentation, site activation, and regulatory submissions.
Role type
Individual contributor clinical trial operations associate
Builds
Global clinical trial documentation, site activation checklists, and regulatory submissions
Domain
Pharmaceutical / Clinical Trials
Required skills
Clinical trial documentation management, Site activation, Regulatory submission, Vendor/CRO coordination, Document review and approval, System updates (CTMS/eTMF), Translation coordination
Preferred skills
Quality control of start-up activities, Standardized template creation, CSR distribution, ICF adaptation
Technologies
CTMS, eTMF
Responsibilities
Manage and execute centralized activities in support of global trials with an emphasis on clinical documentation; Interact with clinical study sites, CROs/vendors, and Country Trial Managers to support study duration; Act as main point of contact for essential document management and ethical/regulatory submission activities; Initiate and manage start-up documentation activities for global clinical trials; Submit potential investigators for debarment review; Responsible for country/Site Activation including final review of documents and sign-off of checklists; Update and review clinical systems to report status of clinical trial documents; Arrange certified translation of study level documentation; Assist with coordination of study specific materials like pharmacy or Investigator site file; Centrally review Site Monitoring Visit reports and manage issue escalation and resolution; Create and manage standardized document templates; Assist with CSR distribution and Country/site level ICF adaptation.
Seniority
Individual contributor, task-level responsibility
