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Clinical Trial Lead - sponsor-dedicated

Laboratory Corporation of America Holdings (Covance)

Munich, Germany

<h2>Job Overview:</h2><p style="margin: 0cm 0cm 3.0pt 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><u>Clinical Trial Lead - sponsor-dedicated</u></span></p><p style="margin: 0cm 0cm 3.0pt 18.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Location: Munich, Germany / Home Office, Germany</span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0cm 1.7pt 3.0pt 18.0pt;"><span style="font-size: 10pt; color: windowtext; font-family: arial, helvetica, sans-serif;">Covance by Labcorp has supported the pharmaceutical industry in developing more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. 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 3.0pt 18.0pt;"><span style="font-size: 10pt; color: windowtext; font-family: arial, helvetica, sans-serif;">If you are looking to take on responsibility, hone your leadership skills and leverage your extensive know-how in clinical trials - ensuring both the success of important clinical studies and meaningful professional development of your team members -, this is the perfect opportunity. You will be working directly with one of our renowned key sponsors, in a role that allows you to have a real impact on people’s health and lives.</span></p><p style="margin: 0cm 1.7pt 3.0pt 18.0pt;"><span style="font-size: 10pt; color: windowtext; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0cm 0cm 3.0pt 18.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">What we have to offer: a strong international support network, flexible working solutions that facilitate a genuine work-life balance, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.</span></p><p style="margin: 0cm 0cm 3.0pt 18.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0cm 0cm 3.0pt 18.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Sounds exciting? Then we would love to hear from you!</span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0cm 0cm 3.0pt 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><u>As Clinical Trial Lead, you typically will:</u></span></p><ul><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Execute and oversee the local clinical trial activities for assigned protocols in compliance with ICH/GCP and German regulations, client policies and procedures, quality standards and adverse event reporting requirements </span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Own both country and site budgets, negotiate and close Clinical Trial Research Agreements, oversee and track payments, reconcile payments at study close-out and ensure accurate data in our financial systems</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Manage and coordinate local processes such as clinical and ancillary supplies management, im- and exporting requirements, supplies destruction, local electronic / hard copy filing, archiving and retention requirements, insurance process management and data quality</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Execute and oversee country submissions and approvals</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Collaborate with Institutional Review Boards (IRBs), Independent Ethics Committees (IECs) and other regulatory authorities </span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Contribute to the development of local materials and best practices</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Collaborate closely with other internal and sponsor departments to ensure all country deliverables are met and aligned with timelines</span></li></ul><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Degree in a relevant field such as pharmacology, life sciences, clinical trial management, health care, nursing, chemistry, biology, oecotrophology etc., </span></li><li><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">In lieu of the above, an equivalent completed vocational education or equivalent professional experience</span></li></ul><h2>Experience:</h2><ul><li><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Deep expertise in clinical trials within a CRO or a pharmaceutical company, including solid independent monitoring experience as sCRA or Lead CRA</span></li><li><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Professional experience with submissions to the German regulatory authorities - observing all local regulations and guidelines as well as international standards such as ICH and GCP</span></li><li><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Leadership skills demonstrated by coaching, mentoring and coordinating teams locally and/or virtually</span></li><li><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Leadership experience in a comparable position (e.g. Clinical Trial Lead, Clinical Research Manager, Study Start-Up Lead, Clinical Safety / Quality Manager etc.) a definite plus</span></li><li><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Autonomous work style with excellent time and project management skills </span></li><li><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Ability to build trustful, sustainable relationships with a wide variety of stakeholders based on your outstanding listening and communication skills</span></li><li><u><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Business fluency in German and English – both spoken and written – is a must</span></u></li></ul><p style="margin-bottom: 3.0pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;"> </span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Remote</span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">#LI-AR1</span></p>

Job posted: 2021-02-26

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