Acts as a communication line for project teams regarding clinical data management
Maintains TMF/eTMF
Trains Assistant Data Manager
Is involved in clinical data management activities including, but not limited to:

Supporting development of study documentation (eCRF Requirements, Edit Checks Specification, Data Management Plan, CRF Completion Guidelines, User Access Management Plan, Data Validation Plan, External Data Transfer Agreements, SAE Reconciliation Guidelines, Local Lab Normal Ranges Guidelines, Coding Guidelines where applicable)
User acceptance testing
User access management
Data review
eCRF/External data reconciliation
Medical coding (for staff with medical/Life Science background)
Supporting SAE reconciliation
Query management
Local lab normal ranges entry and QC
Study Database Lock activities
Archival of CRFs QC
Data entry/QC
Project status reporting
Data listings/Patient profiles generation and delivery
Assisting with Database Lock tasks as needed for assigned projects

College or University degree or equivalent combination of training and experience that presents the required knowledge, skills, and abilities
A minimum of one year of industry experience, preferably working with clinical or medical data

Data Manager for Clinical Trials