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Project Manager Level II - CLS

Laboratory Corporation of America Holdings (Covance)

Shanghai, China

<h2≥Job Overview:</h2≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥The Study Manager is responsible for the successful delivery of the study management activities related to companion diagnostic studies in their specific area of the world.</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥The Study Manager coordinates, plans, organizes and oversees, in his regional location, the completion of administrative and technical tasks during the companion diagnostic study life time in collaboration with the Principal Investigator, the regional laboratory testing site and the various internal departments involved in the deliverables of the study.</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥The Study Manager ensures the three ways communication with the regional Diagnostic Client in their specific area of the word, the Global Study Manager appointed to the Pharma Sponsor and the regional laboratory operations testing site</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥The Study Manager acts as consultant/Technical Expert in providing recommendations/advice to all parties, a-day-to-day project management oversight by managing, planning and coordinating all projects related as well as maintaining study documentation in accordance with customer expectations and in compliance with regulatory requirements.</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥ </span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥In his Global Study Manager role, the Study Manager II is accountable to ensure global consistency of the Diagnostic program across the different laboratory principal investigator testing sites where the diagnostic trial is conducted. He is in charge to coordinate the regulatory aspects with the appropriate operational groups including Medical Affair and Quality Assurance departments</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<strong≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥General duties:</span≥</strong≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Act as ambassador on behalf of the Diagnostic client across Covance departments; exemplifies the concept of Signature Client Service through outstanding, personalized customer service skills</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Act as regional internal liaison to ensure proper and smooth communication between the Diagnostic Sponsor, the PM Global Study Manager, the Principal Investigators/Scientists, the laboratory operation and the various internal departments involved in the study ( Quality Assurance, Commercial Development, Global Laboratory Services Support, Specimen Storage, Data Management, Client Services, Information Technology) develop solutions, resolve issues and approve internal database loading/design plan</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Act as regional external liaison with assigned Diagnostic Client representatives (eg. Diagnostic CRA, Site Monitors, Study Managers) the PM Global Study Manager and the internal clients to ensure an outstanding - timely communication </span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Accountable of the proper and timely delivery of all the regional study related aspects and deliverables from win study notice to the closure of the study by working in close collaboration with the PM Global Study Manager and the Diagnostic Global Study Managers </span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Review the Diagnostic component of study Statement of Work to ensure local feasibility and make appropriate recommendations to the Study Design Lead in collaboration with the PM Global Study Manager and the DDS Global Study Manager</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Act as a remote regional liaison between Global Study Manager and the various internal departments involved in the study.</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Participate in Covance CLS development through continuous process improvement, quality and productivity</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Demonstrate through appropriate self-organization the ability to manage high administrative load</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Able to act efficiently in an environment with dynamic timelines and priorities</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Demonstrate strong interpersonal and communication skills that will build strong internal and external relationships to ensure deliverables are on time and within budget</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥In his Global Study Manager role, the Study Manager I is accountable to:</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Ensure global consistency of the Dx program across the different testing sites location, including lab operation processes harmonization, </span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Implement, monitor, set up local performance metrics and take corrective actions when needed, </span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Pre win consultation support with the Dx client and the commercial development department.</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Manage and monitor the Diagnostic Sponsor budget in collaboration with PM Global study Manager</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥ </span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥ </span≥</p≥<p style="margin: 0in 0in 8pt;"≥<strong≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Principal Day-to-Day duties</span≥</strong≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥ </span≥</p≥<p style="margin: 0in 0in 8pt;"≥<strong≥<span style="color: #00b0f0; font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Day-to-day local study related activities- including but not limited to: (90% of time in a single work week)</span≥</strong≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Prepare, organize and host CRA visits as needed.</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Participate into and prepare Client Audit related to Diagnostic studies</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Prepare, coordinate set up and monitors study timelines and ensure proper coordination with the regional laboratory testing site, the CRA and all internal departments involved </span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Submit regulatory authority applications</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Manage and lead external and internal meetings </span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Track monthly Diagnostic services billable activities</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Report Adverse Events as needed to the global diagnostic Study Manager and Principal Investigator/Scientist</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Report protocol deviations as needed to the global diagnostic Study Manager and Principal Investigator/Scientist</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Ensures that all customer expectations are documented and acted upon in compliance with regulatory requirements</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Serve as back up to Regional Study Coordinators and Study Managers</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Global Study Management responsibilities:</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Ensure laboratory processes harmonization across CLS sites location.</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Ensure Diagnostic protocols and program consistency across CLS sites location </span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Ensure proper escalation of internal misalignment and inconsistencies and propose corrective and preventive actions</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Manage, monitor Diagnostic Client Budgets in coordination with the PM global study manager</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥ </span≥</p≥<p style="margin: 0in 0in 8pt;"≥<strong≥<span style="color: #00b0f0; font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Regulatory/ Study Documentation duties-(10% of time in a single work week)</span≥</strong≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Maintain all necessary study documentation, including but not limited to: study binders, material receipt forms, and material balance forms.</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Maintain all necessary study documentation,: study binders, material receipt forms, and material balance forms</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Participate in team meetings and take minutes</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Organize and Archiving study documentation and correspondence as requested by the client</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Filing and collating trial documentation and reports</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Perform physical inventory of study materials as needed</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Track monthly Diagnostic services billable activities</span≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Report Adverse Events as needed to the global diagnostic Study Manager and Principal Investigator/Scientist</span≥</p≥<p style="margin: 0px;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Report protocol deviations as needed to the global diagnostic Study Manager and Principal Investigator/Scientist  </span≥</p≥<h2≥Education/Qualifications:</h2≥<p style="margin: 0in 0in 0pt;"≥<span style="color: #00b0f0; font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Minimum Required</span≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥:</span≥</p≥<p style="margin: 0in 0in 0pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥BS degree in Biology, Chemistry or other Life Science; or Medical Technologist degree.</span≥</p≥<p style="margin: 0in 0in 0pt;"≥<span style="color: #00b0f0; font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Preferred:</span≥</p≥<p style="margin: 0in 0in 0pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Computer literate</span≥</p≥<p style="margin: 0in 0in 0pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Professional certification (ASCP,PMP or other) in area(s) expertise</span≥</p≥<h2≥Experience:</h2≥<p style="margin: 0in 0in 0pt;"≥<span style="color: #00b0f0; font-family: 'Verdana',sans-serif; font-size: 12pt;"≥Minimum Required: </span≥</p≥<p style="margin: 0in 0in 0pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥3 years of clinical laboratory experience or customer service experience, preferable in pharmaceutical industry. Experience with multidisciplinary lab background is a plus. </span≥</p≥<p style="margin: 0in 0in 0pt;"≥<strong≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥ </span≥</strong≥</p≥<p style="margin: 0in 0in 8pt;"≥<span style="font-family: 'Verdana',sans-serif; font-size: 12pt;"≥ </span≥</p≥

Job posted: 2021-01-25

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