Develop Data Management Plan 

Develop Data Edit Specifications

Database Development/Set-up/Programming 

eCRF Development and Set-Up

Lead Database Validation Process

Develop CRF Completion Guidelines

Perform EDC User Acceptance Testing and Training

Oversee Database management/hosting and status reports

Provide Additional training session (if required)

Query Generation

Query Resolution

Adverse Event (AE) Coding

Concomitant Medication (ConMed) Coding

SAEs Reconciliation

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Receipt of Vendor Electronic Data

(Randomization Center, Central lab, Reading Center, etc... )

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Third Party Data Reconciliation

Database locking and Report

Data export for Client

Provide On-going Data Management  Support 

• Attend team meetings

• Advise on data management topics 

• Attend meetings with partners

• Produce materials for investor or business development presentations