Senior Data Coordinator Validation (GCPA)

<h2>Job Overview:</h2><ul><li style="color: #000000;">Supports validation activities as assigned and serves as a validation team member.</li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;">Review to make oneself familiar with the EDC specifications.</li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;">Writes and assembles validation documentation packages such as but not limited to, validation plan, testing results, traceability matrix, validation reports.</li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;">Support virtual global validation team as needed to complete validation projects</li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;">Maintains and utilizes knowledge of SOPs and validation procedures/standards in relation to system development cycle.</li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;">Executes test cases against requirement, enters errors in error tracking logs and performs re-test documenting resolutions.</li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;">Supports in maintaining testing documentation and files.</li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;">Carry out all activities according to Labcorp SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP).</li></ul><ul><li style="color: #000000;">Perform other duties as assigned by senior staff and/or manager.</li></ul><p style="margin: 0px;"> </p><h2>Education/Qualifications:</h2><ul><li style="color: #000000;">University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology)</li></ul><ul><li style="color: #000000;"><span style="font-size: 11pt;">Basic knowledge of drug development process and Clinical Data Management System.</span></li></ul><ul><li style="color: #000000;">Basic knowledge of relational databases preferred</li></ul><ul><li style="color: #000000;">Fluent in English, both written and verbal</li></ul><h2>Experience:</h2><ul><li style="color: #000000;">Three point five to Six (3.5-6) relevant work experience to include data management and database support:</li></ul><ul><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;">Good problem solving skills and a proactive approach</li></ul><ul><li style="color: #000000;">Good oral and written communication skills</li></ul><ul><li style="color: #000000;">Basic knowledge of clinical trial process to support operations preferred</li></ul><ul><li style="color: #000000;">Ability to work in a team environment</li></ul><ul><li style="color: #000000;">Ability to work effectively under supervision</li></ul><ul><li style="color: #000000;">Ability to prioritize work</li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;">Self-motivated</li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;">Good time management skills and maintain the highest standards of quality work</li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;">A cooperative and team oriented approach</li></ul>