Snr Clin Trials Admin - Lawrenceville, NJ

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Sr. CTA </strong></span></p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Lawrenceville, NJ; Office Based</strong></span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">In this role, the selected candidate will be accountable for the oversight and project management of multiple cross study related deliverables. </span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="color: black;">• Contributes to the operational execution of clinical studies and supports complex global trials as needed.<br />• Provides operational input on development, management and maintenance of study deliverables (i.e. timelines, study plans, documents, etc.) through collaboration with internal and external stakeholders.<br />• Drives process / system enhancements related to GTS responsibilities / deliverables and manage / comply with various quality or compliance systems<br />• Manages country planning, protocol level attributes and milestones/drivers in CTMS.<br />• Manages the development and/or collection of study level documentation, support GTM in ensuring eTMF accuracy and completion for all studies.<br />• Manages the global setup of study level non-clinical supplies.<br /><br />*non-interventional (HEOR, rPMS/PASS), Investigator Sponsored Research (ISR), Early Pateint Access (EPA) and Late Phase interventional programs</span></span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"> </p><p style="margin: 0px;"> </p><h2>Education/Qualifications:</h2><h2 style="text-align: justify;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Minimum Required:</span></h2><ul><li><span style="font-family: arial, helvetica, sans-serif;"><span style="font-family: calibri, sans-serif;"><span style="font-size: 16px;">BA/BS or Associate's in relevant discipline</span></span></span></li><li><span style="font-family: arial, helvetica, sans-serif;"><span style="font-size: 16px;">Basic knowledge of ICH/GCP and regulatory guidelines/directives</span></span></li><li><span style="font-family: arial, helvetica, sans-serif;"><span style="font-size: 16px;">Exp. in managing milestone and drivers in CTMS</span></span></li><li><span style="font-family: arial, helvetica, sans-serif;"><span style="font-size: 16px;">Exp. in managing vendor set up; contracting; cost plans and func creation</span></span></li><li><span style="font-family: arial, helvetica, sans-serif;"><span style="font-size: 16px;">Risk/Issue Identification and escalation</span></span></li><li><span style="font-family: arial, helvetica, sans-serif;"><span style="font-size: 16px;">Management of study trackers, document mgmt (eTMF, archiving), SharePoint sites</span></span></li><li><span style="font-family: arial, helvetica, sans-serif;"><span style="font-size: 16px;">Supports inspection readiness through quality control</span></span></li><li><span style="font-family: arial, helvetica, sans-serif;"><span style="font-size: 16px;">Participates in internal improvement projects</span></span></li><li><span style="font-family: arial, helvetica, sans-serif;"><span style="font-size: 16px;">COVID-19 vaccination required</span></span></li></ul><h2>Experience:</h2><h2 style="text-align: justify;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Minimum Required: </span></h2><ul style="margin-top: 0in;"><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Minimum two (2) years administrative experience or equivalent training/experience</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Good oral and written communication skills</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Proven leadership within the CTA group</span></li></ul><p style="margin-top: 10.1pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Preferred:</strong></span></p><ul style="margin-top: 0in;"><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Aptitude for handling and proof-reading numerical data, some spreadsheet software competency</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Good organizational and time management skills</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Computer literacy (Microsoft Office and spreadsheet software),</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Good typing skills</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Good spelling and proof-reading skills</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Aptitude for handling and reviewing numerical data</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to operate standard office equipment (e.g., fax, copier)</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Works efficiently and effectively in a matrix environment</span></li></ul>