Data Manager for Clinical Trials

1. Acts as a communication line for project teams regarding clinical data management
2. Maintains TMF/eTMF
3. Trains Assistant Data Manager
4. 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

Qualifications :

• 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

Remote Work :

Yes

Employment Type :

Full-time

Experience: years
Vacancy: 1