Clinical Data Manager

November 28

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Parexel

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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 performing Data Management activities that support the sponsor’s projects. • Participate as an active member of a multi-disciplinary team for phase I – IV studies. • Lead or co-lead clinical studies with moderate guidance. • Manage and monitor data management activities with CROs. • Review protocols for data capture including eCRF design. • Develop data edit check specifications and run data listings. • Coordinate the testing of EDC systems. • Resolve EDC system issues and maintain study workbooks. • Perform database lock and freeze activities per company SOPs.

Requirements

• Bachelor’s Degree required (Master's Degree preferred) in the scientific/healthcare field. • At least two years’ experience in Data Management for the pharmaceutical/biotechnology industry. • Understanding of the scope and focus of Phase I – IV clinical studies, and a proven ability to perform some of the core Data Management tasks and interact with vendors. • An 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 Data Management practice. • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. • Strong English language written and verbal communication skills. • Able to travel to meetings or training seminars on occasion. • Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. • Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable. • Experience and understanding of the Oncology or CNS therapeutic area and with Phase III pivotal studies are desirable.