Description
Global Pharmatek LLC has openings in Edison, NJ) Senior Clinical Document Specialist: Assist with document preparation for due diligence, inspections, and internal and external audits. Maintain filing of sponsor study protocol documents and clinical trial documents, adhering to FDA and regulatory agency guidelines. Review eTMF (electronic trial master file) content and identify required relational documents. Stay up to date on regulations, guidelines, policies, and practices for TMF management. Review study documentation for TMF quality for sponsor and CRO studies. Research eTMF or available resources to find answers to the queries at indexing and review stage. Will work in unanticipated locations. Requires Master’s in Chemistry, Pharmaceutical Sciences, Public Health, or related. Send resume to Global Pharmatek LLC 2025 Lincoln Highway Suite 225A, Edison, NJ 08817 or email to hr@globalpharmatek.com