Parexel
Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions
10,000+
💰 Venture Round on 1990-01
Senior Clinical Data Analyst
September 30
Parexel
Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions
10,000+
💰 Venture Round on 1990-01
Description
• Independently lead and coordinate clinical data validation activities. • Provide technical expertise in Data Management operations and documentation. • Ensure compliance with quality standards, SOPs, ICH-GCP, and regulatory requirements. • Act as subject matter experts on DM systems/processes. • Offer technical support to internal and external sponsors. • Fulfill Data Management Lead role when needed. • Prepare and maintain DM documents as per SOPs and guidelines. • Conduct UAT on clinical database setups and review protocols. • Monitor and analyze DM operational metrics. • Maintain compliance, provide on-the-job training, and act as mentor.
Requirements
• Advanced technical aptitude in Microsoft Office and DM systems. • Thorough understanding of DM processes and ICH-GCP guidelines. • Proficiency in at least one Clinical Data Management System (e.g. InForm, Rave, Veeva, DataLabs, ClinBase). • Experience in clinical research industry. • Advanced knowledge of medical terminology and coding dictionaries. • Basic knowledge of SAS and CDISC standards. • Understanding of DM project financials. • Good English skills.
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