Senior External Data Specialist

<h2≥Job Overview:</h2≥<p style="margin: 0px;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥The <strong≥Senior External Data Specialist</strong≥ ensures electronic vendor data contains all protocol specified parameters, is in correct format, and data populates to the specified fields and patients correctly.</span≥</p≥<p style="margin: 0px;"≥ </p≥<p style="margin: 0px;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Position is home-based in the US or Canada.</span≥</p≥<p style="margin: 0px;"≥<span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;"≥ </span≥</p≥<p style="margin: 0px;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Main responsibilities:</span≥</p≥<ul≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Develop Data Transfer Agreement and Data Transfer Specifications for vendor data transfers.</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Create Edit checks for all external data types and perform validation.</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Review data discrepancies generated by study specific edit checks for External data and perform the subsequent query management process in resolving the data issues.</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Perform review of the electronically transmitted data for a sample of total number of patients in the study for loading purposes.</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Develop External Data Status Reports, communicate with vendors and participate in Study team meetings.</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Extensive knowledge of Electronic Data Capture (EDC) systems (RAVE, Inform etc.)</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Collect/track local laboratory normal ranges for all sites.</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Edit and perform QC for local laboratory ranges. Verify that normal ranges are properly attached to patient results in the local lab data collection module.</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Attend External Data Kick off meetings as required by sponsor.</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Ensure project deliverables are met for assigned studies. </span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Provide guidance and training to team members.</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Perform other duties as required by the department.</span≥</li≥</ul≥<h2≥Education/Qualifications:</h2≥<ul≥<li≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Medical Laboratory Technology certificate preferred/Associates or Bachelor’s degree or relevant experience.</span≥</li≥</ul≥<h2≥Experience:</h2≥<ul≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Minimum six (6) years relevant Clinical Data Management experience or an equivalent combination of education and experience to successfully perform the key responsibilities of the job</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Ability to maintain confidentiality of data and information during interactions with staff at all levels</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Demonstrated computer literacy</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Accurate keyboarding skills</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Thorough understanding of medical terminology</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Understanding of ICH-GCP principles</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Demonstrates ability to provide training for EDS levels 1 and 2</span≥</li≥<li style="margin: 1.0pt 0in 1.0pt 1.25in;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Ability to manage EDS team for larger clients</span≥</li≥</ul≥