Lead Clinical Data Manager

Data Management Role

Responsibilities:

Responsible for the oversight of all data management CRO activities supporting company's clinical programs from database start-up through database lock and CSR/submission.

Serves as primary point of contact with the DM CROs, 3rd party vendors and internal study teams.

Works with internal team and DM CRO to develop study timelines and ensures all DM related deliverables are met.

Oversees the development of the clinical database (DB), including user requirements, eCRF, edit rules/checks, data validation and User Acceptance Testing.

Oversees the development of key data management documents such as case report forms (CRF), data validation specifications, manual data review guidelines, CRF Completion Guidelines, programable edit checks, Data Management Plans (DMP) and other related documents. Ensures compliance with these study documents.

Participates in the development of other stu...