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Process Lead

Laboratory Corporation of America Holdings (Covance)

Tokyo, Japan

<h2>Job Overview:</h2><p style="margin: 3.0pt 0cm 3.0pt 0cm;"><strong><u><span style="font-size: 11.0pt; color: black;">Overall</span></u></strong></p><ul><li style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">A</span><span style="font-size: 11.0pt; color: black;">ct as </span><span style="font-size: 11.0pt; color: black;">a subject matter expert on</span><span style="font-size: 11.0pt; color: black;"> process</span><span style="font-size: 11.0pt; color: black;">/quality/training. C</span><span style="font-size: 11.0pt; color: black;">larif</span><span style="font-size: 11.0pt; color: black;">y</span> <span style="font-size: 11.0pt; color: black;">inquirie</span><span style="font-size: 11.0pt; color: black;">s received from operational team</span><span style="font-size: 11.0pt; color: black;">.</span> <span style="font-size: 11.0pt; color: black;"> P</span><span style="font-size: 11.0pt; color: black;">rovide expert advice</span><span style="font-size: 11.0pt; color: black;">/opinion</span><span style="font-size: 11.0pt; color: black;"> and counsel on matters of process</span><span style="font-size: 11.0pt; color: black;">/quality/training</span><span style="font-size: 11.0pt; color: black;"> compliance</span><span style="font-size: 11.0pt; color: black;"> and </span><span style="font-size: 11.0pt; color: black;">interpretation</span><span style="font-size: 11.0pt; color: black;">.</span></li><li style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">C</span><span style="font-size: 11.0pt; color: black;">ollaborate with </span><span style="font-size: 11.0pt; color: black;">team</span> <span style="font-size: 11.0pt; color: black;">members</span><span style="font-size: 11.0pt; color: black;"> to identify improvement opportunities </span><span style="font-size: 11.0pt; color: black;">in </span><span style="font-size: 11.0pt; color: black;">process</span><span style="font-size: 11.0pt; color: black;">/quality/training </span><span style="font-size: 11.0pt; color: black;">based on performance data</span></li><li style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">P</span><span style="font-size: 11.0pt; color: black;">repare </span><span style="font-size: 11.0pt; color: black;">scope and roadmap of </span><span style="font-size: 11.0pt; color: black;">improvement </span><span style="font-size: 11.0pt; color: black;">for </span><span style="font-size: 11.0pt; color: black;">review board</span></li><li style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">E</span><span style="font-size: 11.0pt; color: black;">xecute</span><span style="font-size: 11.0pt; color: black;">, </span><span style="font-size: 11.0pt; color: black;">implement</span><span style="font-size: 11.0pt; color: black;">, and manage </span><span style="font-size: 11.0pt; color: black;">improvement </span><span style="font-size: 11.0pt; color: black;">according to the </span><span style="font-size: 11.0pt; color: black;">agreed</span> <span style="font-size: 11.0pt; color: black;">scope and timelines</span></li><li style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">P</span><span style="font-size: 11.0pt; color: black;">erform impact analysis</span><span style="font-size: 11.0pt; color: black;">,</span><span style="font-size: 11.0pt; color: black;"> develop communication</span><span style="font-size: 11.0pt; color: black;">/</span><span style="font-size: 11.0pt; color: black;">training plan</span><span style="font-size: 11.0pt; color: black;">, and create materials </span><span style="font-size: 11.0pt; color: black;">for the roll out of </span><span style="font-size: 11.0pt; color: black;">the</span><span style="font-size: 11.0pt; color: black;"> improvement</span></li><li style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">P</span><span style="font-size: 11.0pt; color: black;">romote and </span><span style="font-size: 11.0pt; color: black;">encourage</span><span style="font-size: 11.0pt; color: black;"> best practice for assigned area</span></li><li style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">D</span><span style="font-size: 11.0pt; color: black;">evelop system & tool to track process</span><span style="font-size: 11.0pt; color: black;">/quality/training</span><span style="font-size: 11.0pt; color: black;"> compliance</span></li><li style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">May oversee activities within the team and provides appropriate supervision to the members</span></li></ul><p style="margin: 3.0pt 0cm 3.0pt 0cm;"><span style="font-size: 11.0pt; color: black;"> </span></p><p style="margin: 3.0pt 0cm 3.0pt 0cm;"><strong><u><span style="font-size: 11.0pt; color: black;">Process</span></u></strong></p><ul><li style="margin: 1.0pt 0cm 1.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">Propose</span><span style="font-size: 11.0pt; color: black;"> and lead strategic enhancement of existing process/tool/tracking system with a drastic approach for enhancing the efficiency in Japan CTO</span></li><li style="margin: 1.0pt 0cm 1.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">E</span><span style="font-size: 11.0pt; color: black;">nhance process/tool/tracking system in an appropriate manner based on the feedback of CTO or other functions in CDS Japan </span></li><li style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">May act as process owner for </span><span style="font-size: 11.0pt; color: black;">the procedures developed </span><span style="font-size: 11.0pt; color: black;">local</span></li></ul><p style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><strong><u><span style="font-size: 11.0pt; color: black;"> </span></u></strong></p><p style="margin: 3.0pt 0cm 3.0pt 0cm;"><strong><u><span style="font-size: 11.0pt; color: black;">Quality</span></u></strong></p><ul><li style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">D</span><span style="font-size: 11.0pt; color: black;">evelop </span><span style="font-size: 11.0pt; color: black;">company-wide</span><span style="font-size: 11.0pt; color: black;">, long term preventative strategies to eliminat</span><span style="font-size: 11.0pt; color: black;">e</span> <span style="font-size: 11.0pt; color: black;">repeated</span><span style="font-size: 11.0pt; color: black;"> findings</span> <span style="font-size: 11.0pt; color: black;">with</span><span style="font-size: 11.0pt; color: black;"> CTO, QA, GQC and relevant global teams</span></li><li style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">Collaborate with QA and GQC to analyze issue/CAPA trend in addition to findings from audits and CQC visits etc. on regular basis</span></li><li style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">A</span><span style="font-size: 11.0pt; color: black;">ct as CAPA </span><span style="font-size: 11.0pt; color: black;">c</span><span style="font-size: 11.0pt; color: black;">oordinator</span><span style="font-size: 11.0pt; color: black;"> and </span><span style="font-size: 11.0pt; color: black;">as primary point of contact for all </span><span style="font-size: 11.0pt; color: black;">issues</span></li><li style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">R</span><span style="font-size: 11.0pt; color: black;">eview and provide input for CAPA responses ensuring consistency across</span><span style="font-size: 11.0pt; color: black;"> project teams and track </span><span style="font-size: 11.0pt; color: black;">CAPAs in state of compliance </span></li><li style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">Maintain quality related process/tools/tracking system</span></li><li style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">Monitor quality performance</span></li><li style="margin: 3.0pt 0cm 3.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;">May act as </span><span style="font-size: 11.0pt; color: black;">SOP liaison and communicate with Global SOP liaison. Communicate updates on SOPs to Japan CTO. </span></li></ul><p style="margin: 1.0pt 0cm 1.0pt 18.0pt;"><span style="font-size: 11.0pt; color: black;"> </span></p><p style="margin: 1.0pt 0cm 1.0pt 0cm;"><strong><u><span style="font-size: 11.0pt; color: black;">Training</span></u></strong></p><ul><li style="margin: 1.0pt 0cm 1.0pt 18.0pt;"><span style="font-size: 11.0pt; color: #333333;">P</span><span style="font-size: 11.0pt; color: #333333;">roposes strategic training planning with drastic approach</span></li><li style="margin: 1.0pt 0cm 1.0pt 18.0pt;"><span style="font-size: 11.0pt; color: #333333;">Asses</span><span style="font-size: 11.0pt; color: #333333;"> and identify training needs based on the feedback from CTO</span><span style="font-size: 11.0pt; color: #333333;">,</span><span style="font-size: 11.0pt; color: #333333;"> other </span><span style="font-size: 11.0pt; color: #333333;">functions and process owners.</span><span style="font-size: 11.0pt; color: #333333;"> D</span><span style="font-size: 11.0pt; color: #333333;">evelop</span> <span style="font-size: 11.0pt; color: #333333;">trainings based on the identified needs</span><span style="font-size: 11.0pt; color: #333333;">.</span></li><li style="margin: 1.0pt 0cm 1.0pt 18.0pt;"><span style="font-size: 11.0pt; color: #333333;">D</span><span style="font-size: 11.0pt; color: #333333;">evelop and deliver practical training based on results and trend analysis from findings of CQC, CMP, Site Audit etc. to improve quality of clinical trials</span></li><li style="margin: 1.0pt 0cm 1.0pt 18.0pt;"><span style="font-size: 11.0pt; color: #333333;">T</span><span style="font-size: 11.0pt; color: #333333;">ailor and deliver global training programs </span><span style="font-size: 11.0pt; color: #333333;">in a variety of formats (virtual, workshops, etc.)</span> <span style="font-size: 11.0pt; color: #333333;">predominantly for </span><span style="font-size: 11.0pt; color: #333333;">Japan CTO </span><span style="font-size: 11.0pt; color: #333333;">to fit the Japanese learning and clinical research environment</span><span style="font-size: 11.0pt; color: #333333;">. C</span><span style="font-size: 11.0pt; color: #333333;">ommunicate with global training team and </span><span style="font-size: 11.0pt; color: #333333;">relevant </span><span style="font-size: 11.0pt; color: #333333;">local </span><span style="font-size: 11.0pt; color: #333333;">functions (HR, </span><span style="font-size: 11.0pt; color: #333333;">G</span><span style="font-size: 11.0pt; color: #333333;">QC, QA, etc.) to ensure synergy of the over-all training process and goal alignment.</span></li><li style="margin: 1.0pt 0cm 1.0pt 18.0pt;"><span style="font-size: 11.0pt; color: #333333;">P</span><span style="font-size: 11.0pt; color: #333333;">erform follow-up after training </span><span style="font-size: 11.0pt; color: #333333;">to </span><span style="font-size: 11.0pt; color: #333333;">enhance existing </span><span style="font-size: 11.0pt; color: #333333;">training course</span></li><li style="margin: 1.0pt 0cm 1.0pt 18.0pt;"><span style="font-size: 11.0pt; color: #333333;">U</span><span style="font-size: 11.0pt; color: #333333;">pdate training materials and contents in a timely manner aligning global/local requirements and reflecting feedback from training participants</span></li><li style="margin: 1.0pt 0cm 1.0pt 18.0pt;"><span style="font-size: 11.0pt; color: #333333;">May </span><span style="font-size: 11.0pt; color: #333333;">s</span><span style="font-size: 11.0pt; color: #333333;">erve as Train-the-Trainer instructor to ensure consistent </span></li></ul><h2>Education/Qualifications:</h2><ul><li style="margin-left: 21.0pt;"><span style="font-size: 10.0pt; font-family: 'MS 明朝',serif; color: #333333;">学士資格(薬学、医学、生物科学、看護などの分野尚可</span><span style="font-size: 10.0pt; font-family: 'MS ゴシック'; color: #333333;">)</span></li><li style="margin-left: 21.0pt;"><span style="font-size: 10.0pt; font-family: 'MS ゴシック'; color: #333333;">臨床開発モニターや</span><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: #333333;">Training</span><span style="font-size: 10.0pt; font-family: 'MS ゴシック'; color: #333333;">、</span><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: #333333;">Quality</span><span style="font-size: 10.0pt; font-family: 'MS ゴシック'; color: #333333;">関係業務の経験</span><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: #333333;">(</span><span style="font-size: 10.0pt; font-family: 'MS ゴシック'; color: #333333;">医薬品、医療機器</span><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: #333333;">)</span></li><li style="margin-left: 21.0pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: #333333;">GCP(Good Clinical Practice) </span><span style="font-size: 10.0pt; font-family: 'MS ゴシック'; color: #333333;">の知識と実務経験</span></li></ul><h2>Experience:</h2><ul><li style="margin-left: 21.0pt;"><span style="font-size: 10.0pt; font-family: 'MS Pゴシック';">5年以上の臨床開発モニター経験</span></li><li style="margin-left: 21.0pt;"><span style="font-size: 10.0pt; font-family: 'MS Pゴシック';">ビジネスレベル以上の英語力</span><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">(</span><span style="font-size: 10.0pt; font-family: 'MS Pゴシック';">読み書き、会話</span><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">)</span></li><li style="margin-left: 21.0pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Training</span><span style="font-size: 10.0pt; font-family: 'MS Pゴシック';">や</span><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Quality</span><span style="font-size: 10.0pt; font-family: 'MS Pゴシック';">関係の業務の</span><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">2</span><span style="font-size: 10.0pt; font-family: 'MS Pゴシック';">年以上の経験が望ましい</span></li></ul>

Job posted: 2021-10-11

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