Summary:

This position is responsible for the
oversight of all CRO data management aspects to ensure data management
performance is in a manner consistent with company SOPs.

PLEASE REFERENCE JOB CODE 4107 WHEN APPLYING FOR THIS POSITION

Essential Duties and Responsibilites:

• Provide input into the development of data management SOPs and processes
• Participate in regular team meetings and provide input when appropriate
• Interact with Acorda and CRO: CRAs, programmers, study managers, and statisticians
• Creation of CRFs and annotated CRFs
• Create database specifications and laboratory specifications for central lab vendors
• Create completion guidelines, data management plans, validation guidelines, and edit check specifications
• Interact with team members in database lock

Education and Experience:

BS or equivalent experience, preferably in the scientific/health care field with at least 5 years in Data Management for the pharmaceutical/biotechnology industry would be the minimum requirement.

Other Skills and Abilities:

• Experience and knowledge with controlled terminology systems such as MedDRA, WHODrug.
• Strong language (written and verbal) communication skills
• Experience with electronic data capture systems and CDISC
• Experience with relational databases.
• An understanding of regulatory guidelines and their application to data management practice.