Senior Data Manager

November 21

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ClinChoice

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Full-Service CRO • Clinical Development • Post-Marketing & Real-World Evidence • Quality and Compliance • Technology

1001 - 5000 employees

Founded 1998

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? • ClinChoice is searching for a Senior Data Manager Consultant to join one of our clients. • The Senior Data Manager works as an integral part of a cross-functional team through the lifecycle of the studies from design through final analysis and study closeout. • The individual is accountable for ensuring study launch, conduct, and closeout are performed according to client quality standards, Good Clinical Practices (GCPs), and International Conference on Harmoization (ICH) guidelines to be compliant with all federal and local regulations.

Requirements

• Minimum BA/BS in scientific or health-related field. • Minimum of 5 - 7 years of clinical data management experience in the pharmaceutical, biotechnology industry or in a CRO. • Either oncology or auto-immune experience required. • Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to DM practice • Proficient with Medidata RAVE. • Experience with working on Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred • Familiarity with various data visualization, analytics, and reporting tools is a plus • Excellent communication skills (verbal and writing). • Ability to multi-task and take on new responsibilities as needed in a fast-paced, small company setting. • Experienced using Microsoft Office applications (Word, Excel, PowerPoint, etc.) • Strong organizational skills and ability to prioritize tasks. • Proven ability to work independently and in a team setting.