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STUDY START-UP SPECIALIST, PARIS

Laboratory Corporation of America Holdings (Covance)

Rueil-Malmaison, France

<h2>Job Overview:</h2><p style="margin: 0cm 1.7pt .0001pt 0cm;"><strong><span style="font-size: 11.0pt; color: windowtext;">Completing the enrollment of the first patient. Without delays, without mistakes. </span></strong></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;"><span style="font-size: 11.0pt; color: windowtext;">This is what our Start-up Specialists live for: orchestrating the activities that will allow sites to be activated fast so they can immediately begin to screen patients.</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;"><span style="font-size: 11.0pt; color: windowtext;">Covance is now Labcorp drug development.</span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: windowtext;"> </span></p><p style="margin-right: 1.7pt;"><span style="font-size: 11.0pt; color: windowtext;">Labcorp was named to </span><strong><em><span style="font-size: 11.0pt; color: windowtext;">Fast Company magazine’s list of 2021 Most Innovative Companies</span></em></strong><span style="font-size: 11.0pt; color: windowtext;"> for its leadership in scientific innovation in the fight against COVID-19. Labcorp´s Drug Development Business, Covance, was recognized with the </span><span style="font-size: 11.0pt; color: windowtext;"><em><strong>2020 Global CRO Company of the Year Award</strong></em> by Frost & Sullivan</span><span style="font-size: 11.0pt; color: windowtext;"> for our capacity to integrate digital technologies, remote monitoring, and telemedicine services to ensure continuity of and decentralizing clinical trials.</span></p><p style="margin-right: 1.7pt;"><span style="font-size: 11.0pt; color: windowtext;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: windowtext;">We are now seeking our next <strong>Start-up Specialist</strong> with CRO/ Pharmaceutical background for our new job in Paris.</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;"> </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: 11.0pt; color: windowtext;">THE JOB</span></strong></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;"><span style="font-size: 11.0pt; color: windowtext;">On a normal day, you will find yourself interacting with CRAs, sites, ECs and international project teams in the delivery of the Start-up component of your assigned studies. </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: windowtext;"> </span></p><ul><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 11.0pt; color: windowtext;">You will be the main primary contact for sites and will drive the collection, tracking and quality review of all essential & investigator documents. </span></li></ul><p style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 11.0pt; color: windowtext;"> </span></p><ul><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 11.0pt; color: windowtext;">You will take ownership of the submissions to ECs and Third Bodies (Physician Council, Transparency) in France, and we will need your wise input answering submission/approval issues. </span></li></ul><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: windowtext;"> </span></p><ul><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 11.0pt; color: windowtext;">We will trust you to adapt and customize ICF, patient facing and other essential documents as per EC´s requirement and the management of translations for France. </span></li></ul><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: windowtext;"> </span></p><ul><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 11.0pt; color: windowtext;">You will also manage contracts and budgets with the monitoring of agreements established with hospitals, sites and service providers.</span></li></ul><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: windowtext;"> </span></p><ul><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 11.0pt; color: windowtext;">eTMF and CTMS ongoing monitoring and updating of databases for milestones </span></li></ul><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;"><span style="font-size: 11.0pt; color: windowtext;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: windowtext;">From the initial project specific planning to Site Activation green light and maintenance– that´s you.</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;"><span style="font-size: 11.0pt; color: windowtext;">To thrive in this job, you must:</span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: windowtext;"> </span></p><ul><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 11.0pt; color: windowtext;">Be a </span><strong><span style="font-size: 11.0pt; color: windowtext;">site-relationship builder</span></strong><span style="font-size: 11.0pt; color: windowtext;">: you are experienced in getting sites to provide you with the documents you need on time (and with non-responsive sites, you know how to balance the “push” with being friendly)</span></li><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 11.0pt; color: windowtext;">Be our </span><strong><span style="font-size: 11.0pt; color: windowtext;">ECs/Third Body Parties Confident</span></strong><span style="font-size: 11.0pt; color: windowtext;">: when they raise submissions/ approval questions, you know how to ask, listen and really understand their need, and you know how to answer them in an exact and diplomatic manner too.</span></li></ul><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;"><span style="font-size: 11.0pt; color: #0a0a0a;">Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers. </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: #0a0a0a;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: #0a0a0a;">We can offer you not only a job, but a stable, long-term international career.</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;"><span style="font-size: 11.0pt; color: #0a0a0a;">EMEA AND THE SAME JOB REF</span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: #0a0a0a;">#LI-NC1 EMEA  Remote</span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: windowtext;"> </span></p><h2>Education/Qualifications:</h2><p style="margin: 0px;">BAC +5 degree in one of the life Sciences, <span style="font-size: 11.0pt; font-family: 'Times New Roman',serif;">or certification in a health related profession from an accredited institution (e.g. nursing, medical or lab technology, etc.)</span></p><h2>Experience:</h2><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: windowtext;">IS THIS YOU?</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;"><span style="font-size: 11.0pt; color: windowtext;">Please note this is </span><em><strong><span style="font-size: 11.0pt; color: windowtext;">not an entry level job</span></strong></em><span style="font-size: 11.0pt; color: windowtext;">: </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: windowtext;"> </span></p><ul><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 11.0pt; color: windowtext;">We need someone with minimum 2 years of Site Start-Up experience in ph I to IV clinical trials in France, including working knowledge of ICH-GCP and IRB/IEC regulations</span></li><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 11.0pt; color: windowtext;">We are happy to also hear from CRAs or Regulatory specialists.</span></li></ul><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;"><span style="font-size: 11.0pt; color: windowtext;">This is a </span><span style="font-size: 11.0pt; color: windowtext;">full-time</span><span style="font-size: 11.0pt; color: windowtext;"> job linked to our </span><span style="font-size: 11.0pt; color: windowtext;">Rueil-Mailmaison<span style="font-size: 10.0pt; font-family: 'Calibri',sans-serif; color: #1f4e79;"> </span></span><span style="font-size: 11.0pt; color: windowtext;">office. </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;"><span style="font-size: 11.0pt; color: windowtext;">For more junior profiles, they will need to work office based (when COVID-19 allows us to come back to the office normally). For more experienced, we are ready to offer a weekly home/office combination.</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;"><span style="font-size: 11.0pt; color: windowtext;">Business proficiency in French and English - both spoken and written</span><span style="font-size: 11.0pt; color: windowtext;"> – is a must for this job.</span></p>

Job posted: 2021-11-17

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