Clinical Data Manager

November 28

Apply Now

Receive Emails with Similar Jobs

Parexel

WebsiteLinkedInAll Job Openings

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

• Lead a small clinical study or co-lead a larger study or studies with moderate guidance. • Support several clinical studies with minimal guidance. • Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies. • Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design. • Perform a thoroughly detailed review of eCRF data requirements. • Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines. • Develop data edit check specifications and run data listings as required. • Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. • Able to resolve EDC system issues with team members. • Develop the Data Management Plan for a clinical study. • Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications. • Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries. • Perform reconciliation of header data from external data sources against the clinical database. • Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines. • Assist in database upgrades/migrations including performing User Acceptance Testing. • Able to maintain study workbooks and data management files. • Perform database lock and freeze activities per company SOPs. • Provide input into the development of data management SOPs, Work Instructions, and process documents.

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.