Clinical Project Assistant

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong><span style="color: windowtext;">New Covance job open: Clinical Trial Assistant, CTA. Sponsor dedicated, office based Lisbon. </span></strong></span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; color: windowtext; font-size: 12pt;"> </span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; color: windowtext; font-size: 12pt;"> </span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; color: windowtext; font-size: 12pt;">This is a <strong><em>permanent </em></strong>position at Covance, office based (Oeiras district), and will be working sponsor dedicated with a large Pharmaceutical company in cutting edge Therapeutic areas like Oncology, Cardiology or Diabetes.</span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;">We need you to have some experience either at a CRO, Sponsor or Clinical Trials Hospital Unit, in the following areas: </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 12pt; color: #1f497d; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><u><span style="color: windowtext;">Submissions</span></u></span></strong></p><ul><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;">You will be the preferential contact person with both Health Authorities & Central Ethics Committee to ensure appropriate follow-up of all submitted Clinical Trials and obtain the corresponding authorizations.</span></li><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;">You will coordinate with local Monitoring Teams: the preparation of the CTA documentation to ensure its submission according to established timelines and the preparation of responses to clarifications requested by Health Authorities or Central Ethics Committee.</span></li><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;">Notify both Health Authorities & Central Ethics Committee any relevant information related to Clinical Trials (e.g. amendments, end of trial, etc.).</span></li><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;">Coordinate submissions to National Data Protection Committee.</span></li></ul><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><u><span style="color: windowtext;">Contract management</span></u></span></strong></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;"> </span></p><ul><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;">Be the preferential contact person with the Administration Boards for contract negotiation and management.</span></li><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;">You will establish master agreements with key 1 hospitals in order to speed-up the contract negotiation.</span></li></ul><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong><u><span style="color: windowtext;">Harmonization of several transversal activities</span></u></strong><span style="color: windowtext;">: </span></span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;">We will trust you to organize central filing of common regulatory documentation (CVs, GCP training, Data Privacy, Lab. Ranges, Etc.)</span></p><h2>Education/Qualifications:</h2><p style="margin: 0px;">*</p><h2>Experience:</h2><p style="margin: 0cm 1.7pt .0001pt 0cm;"> </p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;">You bring some CTA or Study Nurse or Study Coordinator experience working at a CRO, Sponsor or Clinical Trials Hospital Unit, ideally in international ph I-IV clinical trials.</span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;">Excellent Portuguese and English language is required, both spoken and written.</span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 12pt; color: windowtext; font-family: arial, helvetica, sans-serif;">Your aptitude for handling and proofreading numerical data and your spreadsheet software competency will be essential to avoid delays and issues during the course of the project</span></p>