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Study Design Lead(Central Laboratory Services)

Laboratory Corporation of America Holdings (Covance)

Tokyo, Japan

<h2>Job Overview:</h2><ol style="margin-top: 0in;"><li><strong><span style="font-size: 11.0pt;">Takes the lead to accurately interpret and translate protocol requirements in to SOW document</span></strong></li><li><strong><span style="font-size: 11.0pt;">Leverages technical, therapeutic area, client and Covance process knowledge to provide a comprehensive and complete SOW document. </span></strong></li><li><strong><span style="font-size: 11.0pt;">Liaise with internal departments to understand Covance capabilities and assess feasibility of requests in order to meet client needs related to study design</span></strong></li><li><strong><span style="font-size: 11.0pt;">Demonstrates strong knowledge of Covance processes and technical capabilities</span></strong></li><li><strong><span style="font-size: 11.0pt;">Acts as a consultant to the client to advise on study design choices and works with GSM to highlight risks and budget impacts associated with study design</span></strong></li><li><strong><span style="font-size: 11.0pt;">Displays strong interpersonal and communication skills that will build strong internal and external relationships to ensure high quality study design</span></strong></li><li><strong><span style="font-size: 11.0pt;">Coordinates internal processes and communications related to study design (including but not limited to: internal feasibility requests, material transfer agreements and supply forecasting) and ensures the eventual follow up is integrated in to the SOW and global monitoring plan. Performs quality self-review</span></strong></li><li><strong><span style="font-size: 11.0pt;">Ensures that all customer requirements with relation to study design are documented and acted upon</span></strong></li><li><strong><span style="font-size: 11.0pt;">Able to act efficiently in an environment with dynamic timelines and priorities</span></strong></li><li><strong><span style="font-size: 11.0pt;">Displays appropriate self organization and ability to manage conflicting priorities</span></strong></li><li><strong><span style="font-size: 11.0pt;">Participate in functional meetings (eg. CLFs) and provide input, keeping processes up to date</span></strong></li><li><strong><span style="font-size: 11.0pt;">Comply with CCLS Global Project Management strategy</span></strong></li><li><strong><span style="font-size: 11.0pt;">Support a culture of continuous improvement, quality and productivity</span></strong></li><li><strong><span style="font-size: 11.0pt;">Other duties as assigned</span></strong></li></ol><p style="margin: 0px;"><strong><span style="font-size: 11.0pt;">                                                                 </span></strong></p><p style="margin: 0px;"><span style="font-size: 11.0pt;">The Study Design Lead is expected to interact with external clients regularly throughout all duties and responsibilities mentioned above.</span></p><h2>Education/Qualifications:</h2><h2>Minimum Required:</h2><ul style="margin-top: 0in;"><li style="color: black;"><span style="font-size: 11.0pt;">High School Diploma</span></li></ul><p style="margin: 0px;"><strong><span style="font-size: 11.0pt; color: black;">Preferred:</span></strong></p><ul style="margin-top: 0in;"><li style="color: black;"><span style="font-size: 11.0pt;">University degree in a</span> <span style="font-size: 11.0pt;">scientific field</span></li></ul><p style="margin: 0px;"> </p><h2>Experience:</h2><h2>Minimum Required:</h2><ul style="margin-top: 0in;"><li><strong><span style="font-size: 11.0pt;">7 years of previous experience in a CCLS Project Management and/or  Clinical Database Design role; or other equivalent industry experience in designing clinical databases (education may be substituted for experience)</span></strong></li></ul><p style="margin-left: .25in;"><strong><span style="font-size: 11.0pt;"> </span></strong></p>

Job posted: 2021-12-08