EDC Validation Expert
Hawkins Point Partners, United States
Job Description
Hawkins Point is looking to add an Electronic Data Capturing Validation Expert to our team. They play a very important role in guaranteeing correct data collection during clinical trials, at the clinical sites. The EDC Validation Expert makes the eCRF, IXRS and/or ePRO-tools fit for use and tests tool specifications through User Acceptance Testing, based on the clinical trial protocol and sponsor's requirements.
Hawkins Point is looking for this person to pull together the data and provide data management expertise to bring clinical studies on-line, including leading the testing activities, conducting and administrating test scripts, collecting and documenting test results and reports, monitoring project timelines and create the Test Plan Reports. The data is with various sources currently.
Requirements
- Working experience with Medidata RAVE or other major EDC system
- Potentially the need is to have the resource Develop and coordinate tests scripts, testing activities, test plan and reports for database quality validation and/or user acceptance testing to ensure accurate database structure and appropriate data collected.
- Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution.
- Generate and maintain functional specifications for the EDC tool Data Validation Rules
- Coordinate User Acceptance Testing
- Work collaboratively with the clients team, Data Management, Programmers,
- Assist in the study database design and validation activities.
- Authoring and execution of validation scripts for clinical reports.
- Basic project management skills.
- Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills.
Benefits
At Hawkins Point Partners we believe in creating great experiences for our colleagues. We offer competitive compensation along with comprehensive benefit options to meet the diverse needs of our colleagues in their personal and professional lives.