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Senior Start-Up Specialist (Clinical Operations Manager)

Laboratory Corporation of America Holdings (Covance)

Portugal

<h2>Job Overview:</h2><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif; color: black;">Across the globe, we keep intact our commitment to improve health and improve lives, and are looking for exceptional people who are eager to play an important role pushing new frontiers in how we diagnose, monitor and treat patients. </span></p><p style="margin: 0px;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif; color: black;"> </span></p><p style="margin: 0px;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif; color: black;">Our Drug Development business continues to support and meet the needs of our pharmaceutical and biotechnology client partners: we continue to initiate new studies from Early Development through Phase IV, and our Central Labs are fully operational. </span></p><p style="margin: 0px;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif; color: black;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-family: arial, helvetica, sans-serif;"><span style="font-size: 11.0pt; color: black;">In this spirit, we would like to introduce you </span><span style="font-size: 11.0pt; color: windowtext;">an unique job opportunity in Italy for an experienced </span><strong><span style="font-size: 11.0pt; color: windowtext;">Study Start up Specialist / Site Activation Associate</span></strong><span style="font-size: 11.0pt; color: windowtext;">, to work </span><strong><span style="font-size: 11.0pt; color: windowtext;">sponsor dedicated</span></strong><span style="font-size: 11.0pt; color: windowtext;"> for a Top 5 global Pharmaceutical company.</span></span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11pt; 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;"><span style="font-size: 11.0pt; color: windowtext;">This job is<strong> home/</strong></span><span style="font-size: 11.0pt; color: windowtext;"><strong>office based</strong> in <strong>Italy</strong></span><span style="font-size: 11.0pt; color: windowtext;">.</span></span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"> </p><p style="margin: 0px;"><span style="font-size: 11pt; font-family: arial, helvetica, sans-serif; color: black;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><strong><span style="font-size: 11pt; color: windowtext; font-family: arial, helvetica, sans-serif;">THE START UP/ SITE ACTIVATION JOB</span></strong></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11pt; color: windowtext; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0cm; margin-bottom: .0001pt;"><span style="font-size: 11pt; font-family: arial, helvetica, sans-serif;">In this job, you will have a significant impact on how Portugal can deliver country-specific Start up commitments and objectives. You will oversee local operational Start up activities in the following areas for your assigned protocols: </span></p><p style="margin: 0cm; margin-bottom: .0001pt;"><span style="font-size: 11.0pt;"> </span></p><p style="margin: 0cm; margin-bottom: .0001pt;"><strong><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Financial:</span></strong></p><ul><li style="margin: 0cm 0cm .0001pt 36.0pt;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Assistance with the ownership of country and site budgets. </span></li><li style="margin: 0cm 0cm .0001pt 36.0pt;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Development, negotiation and completion of Clinical Trial Research Agreements and clinical and financial contracts within fair market value. </span></li><li style="margin: 0cm 0cm .0001pt 36.0pt;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Oversight and tracking of clinical research-related payments. </span></li><li style="margin: 0cm 0cm .0001pt 36.0pt;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Payment reconciliation at study close-out.</span></li></ul><p style="margin: 0cm 0cm .0001pt 36.0pt;"><span style="font-size: 11.0pt;"> </span></p><p style="margin: 0cm; margin-bottom: .0001pt;"><span style="font-size: 11.0pt;"> </span></p><p style="margin: 0cm; margin-bottom: .0001pt;"><strong><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Country Submissions & Local Language materials:</span></strong></p><ul><li style="margin: 0cm 0cm .0001pt 36.0pt;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Responsible for execution and oversight of clinical trial country submissions and approvals.</span></li><li style="margin: 0cm 0cm .0001pt 36.0pt;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Development of local language materials including local language Informed Consents and translations.</span></li></ul><p style="margin: 0cm; margin-bottom: .0001pt;"><span style="font-size: 11.0pt;"> </span></p><p style="margin: 0cm; margin-bottom: .0001pt;"><strong><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Quality Oversight:</span></strong></p><ul><li style="margin: 0cm 0cm .0001pt 36.0pt;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Country deliverables, timelines and results for assigned protocols to meet country commitments.</span></li><li style="margin: 0cm 0cm .0001pt 36.0pt;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Quality and compliance in your protocols, contributing to the development of local SOPs. </span></li></ul><p style="margin: 0cm; margin-bottom: .0001pt;"><span style="font-size: 11.0pt;"> </span></p><p style="margin: 0cm; margin-bottom: .0001pt;"><span style="font-size: 11.0pt;"> </span></p><p style="margin: 0cm; margin-bottom: .0001pt;"><strong><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Local Process Oversight:</span></strong></p><ul><li style="margin: 0cm 0cm .0001pt 36.0pt;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Oversight and coordination of local processes.</span></li><li style="margin: 0cm 0cm .0001pt 36.0pt;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Problem solving and Process Improvement is essential to this position (i.e., issues with budget / CTRA negotiations, Quality and Compliance, Regulatory and legal issues or related to functional area deliverables that could jeopardize protocol milestones.)</span></li></ul><p style="margin: 0px;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif; color: black;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: windowtext;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><strong><span style="font-size: 11pt; color: windowtext; font-family: arial, helvetica, sans-serif;">WHAT MAKES THIS JOB SPECIAL: COLLABORATION</span></strong></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11pt; color: windowtext; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11pt; color: windowtext; font-family: arial, helvetica, sans-serif;">This will be a enriching opportunity because, on top of the above experience,  you will work in close collaboration:</span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11pt; color: windowtext; font-family: arial, helvetica, sans-serif;"> </span></p><ul><li style="margin: 0cm 1.7pt .0001pt 39.0pt;"><span style="font-family: arial, helvetica, sans-serif;"><strong><span style="font-size: 11.0pt; color: windowtext;">Internally</span></strong><span style="font-size: 11.0pt; color: windowtext;"> with the Clinical Country Operations team of managers, CRAs and CTCs, but also Quality Managers, Finance, Medical Affairs, Regulatory Affairs, PharmacoVigilance, Legal  and regional operations & Head Quarter functional areas. </span></span></li><li style="margin: 0cm 1.7pt .0001pt 39.0pt;"><span style="font-family: arial, helvetica, sans-serif;"><strong><span style="font-size: 11.0pt; color: windowtext;">Externally</span></strong><span style="font-size: 11.0pt; color: windowtext;"> with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. </span></span></li></ul><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11pt; color: windowtext; font-family: arial, helvetica, sans-serif;"> </span></p><h2>Education/Qualifications:</h2><ul><li style="margin: 0cm 0cm .0001pt 36.0pt;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (nursing certification, medical or laboratory technology)</span></li><li style="margin: 0cm 0cm .0001pt 36.0pt;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Thorough knowledge of ICH Guidelines and GCP, including a basic understanding of <strong>regulatory requirements in Italy</strong></span></li><li style="margin: 0cm 0cm .0001pt 36.0pt;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Thorough understanding of the drug development process</span></li><li style="margin: 0cm 0cm .0001pt 36.0pt;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif;">Fluent in Italian & English</span></li></ul><h2>Experience:</h2><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11pt; color: #0a0a0a; font-family: arial, helvetica, sans-serif;">For this job, we can consider candidates with:</span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11pt; color: #0a0a0a; font-family: arial, helvetica, sans-serif;"> </span></p><ul><li style="margin: 0cm 1.7pt .0001pt 18.0pt;"><span style="font-size: 11pt; color: windowtext; font-family: arial, helvetica, sans-serif;">Significant clinical Start up/ Site Activation experience in a sponsor/CRO (minimum 2 years)  </span></li><li style="margin: 0cm 1.7pt .0001pt 18.0pt;"><span style="font-size: 11pt; color: windowtext; font-family: arial, helvetica, sans-serif;">Working knowledge of ICH, FDA, Portuguese regulatory requirements, IRB/IEC and other applicable regulations/guidelines</span></li><li style="margin: 0cm 1.7pt .0001pt 18.0pt;"><span style="font-size: 11pt; color: windowtext; font-family: arial, helvetica, sans-serif;">Familiarity with investigator start up documents; previous interaction with operational project team and investigative sites</span></li></ul>

Job posted: 2021-11-17

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