Sr. Global Trial Acceleration Associate
Core
Senior role delivering centralized clinical operations activities to accelerate clinical trial start-up, regulatory submissions, and site operational activities globally.
Role type
Senior Global Trial Acceleration Associate (Centralized Clinical Operations)
Builds
Clinical trial start-up packages, regulatory submissions, site activation documentation, and operational trackers for global studies.
Domain
Pharmaceutical clinical development and regulatory affairs
Required skills
Clinical trial start-up management, regulatory documentation preparation, stakeholder coordination, risk identification, process improvement, cross-functional collaboration, financial processing for clinical trials, audit readiness, GCP compliance
Preferred skills
Advanced degree, CTMS (Veeva Vault) experience, knowledge of clinical trial enabling technologies
Technologies
CTMS, eTMF, SharePoint, MS Office suite
Responsibilities
Independently manage and execute centralized clinical trial start-up and regulatory activities; prepare and coordinate clinical trial package (CTP) approvals; manage Informed Consent Form (ICF) adaptations; prepare Ethics Committee submission dossiers; maintain On-site Investigator Files; process site-level financial activities and purchase orders; coordinate study insurance; support feasibility and site selection; manage Subject-Related Injury reimbursements; ensure adherence to SOPs and GCP; maintain inspection-ready documentation; identify and escalate operational risks; support audit and inspection readiness; provide peer support to junior members; contribute to process improvement initiatives; own operational trackers; provide status updates to stakeholders.
Seniority
Senior, hands-on IC with autonomy and accountability
