Parexel
Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions
10,000+ employees
Founded 1983
⚕️ Healthcare Insurance
🧬 Biotechnology
💊 Pharmaceuticals
💰 Venture Round on 1990-01
ICRA-SSU Administrator
4 days ago
Parexel
Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions
10,000+ employees
Founded 1983
⚕️ Healthcare Insurance
🧬 Biotechnology
💊 Pharmaceuticals
💰 Venture Round on 1990-01
Description
• Responsible for ensuring completeness of Site Essential Document Packages • Review essential documents, tracking and ensuring all files are in place in the eTMF • Gathers all documents required for enabling Site Initiation • Reviews investigator site essential documentation packages from CROs per process • May collaborate directly with sites regarding collection of documents and IRB timelines
Requirements
• 3 years in essential or regulatory document management in Pharmaceutical /CRO industry • understanding of clinical study start up requirements and working knowledge of relevant documentation • Strong familiarity with EUCTD/R and Federal Code of Regulations • Familiarity with Veeva Vault Clinical for CTMS and eTMF use • Excellent verbal and written influencing and training/mentoring skills, in local language and English • Strong coordination and organizational skills
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