Creates and executes the study TMF Plan and ensures team understanding of expectations.
Monitors and reports on TMF Health to internal team and sponsor, identifying trends and risks.
Serves as point of contact for audits and inspections, and supports process improvement initiatives.
Precision for Medicine is a clinical research organization that provides services for drug development, including trial management and regulatory compliance. The company fosters a collaborative environment with a focus on quality and innovation.
Independently manage ICSR triage, case processing, and quality control for global safety reports.
Perform SAE reconciliation between safety and clinical databases, ensuring compliance with timelines.
Support team development through training, onboarding, and process improvement initiatives.
This company is a partner organization focused on global pharmacovigilance operations. It is a fast-growing, internationally focused company with a collaborative culture emphasizing teamwork, excellence, and continuous improvement.
Support study execution by managing meeting logistics, documenting decisions, and tracking action items.
Partner with Clinical Operations and site monitors to ensure protocol compliance and quality standards.
Responsible for filing site-level documents into Trial Master Files and assisting with regulatory submissions.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. As a small, mission-driven team, we foster a collaborative culture built on trust, ownership, curiosity, and results.