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AD Clin Ops

Laboratory Corporation of America Holdings (Covance)

Tokyo, Japan

<h2>Job Overview:</h2><p style="margin: 0px;"><strong><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">People Responsibilities:</span></strong></p><ul><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif; color: #333333;">Supervision of Clin Ops managers</span></span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Responsible for the supervision of assigned direct reports </span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Responsible for detailed performance review and management of assigned direct reports including: Annual Performance Management and Development (PMD), Individual Development Plan (IDP), Line of Sight Goals and “Shoves & Tugs”</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Responsible for appropriate management and resolution of performance issues</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Measure performance indicators for assigned staff within Clinical Operations.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Identify individual training needs and assist in the conduct of training and development efforts, regionally</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Conduct on-site Accompanied Field Visit activities (Evaluation and Quality Control Visits) for Clinical Operations staff</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Effectively communicate management strategies, policies and procedures in conjunction with leadership teams </span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Develop and maintain effective relationships with management team to manage Clinical Operations staff in a matrix environment.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business.</span></li></ul><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;"> </span></p><p style="margin: 0px;"><strong><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Indicate the number of:</span></strong></p><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Direct Reports: Between 10 and 20 Clinical Operations Staff dependent upon business need</span></p><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Indirect Reports: None</span></p><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;"> </span></p><p style="margin: 0px;"><strong><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">GCP Oversight Accountability</span></strong></p><ul style="margin-top: 0cm;"><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Has GCP oversight of direct reports by ensuring GCP training is executed, understood and implemented.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Identify and escalate GCP issues identified through regular interactions with direct reports and conduct of Accompanied Field Visits</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Ensures training record compliance with training matrix and ensures training records are up to date</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Provide input to relevant SOPs and standard plans/templates for use by Project Management and Clinical Operations staff.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Assist with on-boarding of new direct reports ensuring GCP training before monitoring begins</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Hold Clinical Operations staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Hold Clinical Operations staff accountable for compliance with project plan and adherence to contract obligations in Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Coach Clinical Operations staff to own effective Investigator relations and Investigator oversight at the local level.</span></li></ul><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;"> </span></p><p style="margin: 0px;"><strong><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Productivity/Financial Management</span></strong></p><ul style="margin-top: 0cm;"><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Communicate status of assigned workload for metric reporting</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Perform weekly review of direct report billable hours and associated utilization per the quarterly and annual budget plan, and escalation of outliers to management team for mitigation </span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Escalates available workload hours, in context of project allocation, supply and demand, to management team</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Adheres to global tools for monitoring and utilization forecasting</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Engage in Resource management activities for direct reports</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Assist with staff recruitment through screening and interviewing</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Financial authority in accordance with current signature approval matrix</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Liaise with internal and external customers in relevant process improvement initiatives, including Six Sigma</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Schedule Accompanied Field Visits to ensure costs are in alignment with regional budget.</span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0px;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif; color: windowtext;">- </span><span style="font-size: 11.0pt; font-family: 'MS Pゴシック'; color: windowtext;">学士資格(薬学、医学、生物科学、看護などの分野尚可)</span></p><p style="margin: 0px;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif; color: windowtext;">- GCP(Good Clinical Practice) </span><span style="font-size: 11.0pt; font-family: 'MS Pゴシック'; color: windowtext;">の知識と関連する指導経験</span></p><p style="margin: 0px;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif; color: windowtext;">- </span><span style="font-size: 11.0pt; font-family: 'MS Pゴシック'; color: windowtext;">ビジネス上級レベルの英語、日本語スキル</span><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif; color: windowtext;">(</span><span style="font-size: 11.0pt; font-family: 'MS Pゴシック'; color: windowtext;">読み書き、会話</span><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif; color: windowtext;">)</span></p><h2>Experience:</h2><p style="margin: 0px;"><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif; color: #333333;">- 15</span><span style="font-size: 11.0pt; font-family: 'MS 明朝',serif; color: #333333;">年以上の医薬品臨床開発の知識と経験</span><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif; color: #333333;"> (</span><span style="font-size: 11.0pt; font-family: 'MS 明朝',serif; color: #333333;">モニタリング、プロジェクトマネジメント</span><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif; color: #333333;">)<br />- </span><span style="font-size: 11.0pt; font-family: 'MS 明朝',serif; color: #333333;">クライアントとの直接のやり取りを含むプロジェクトマネジメント経験</span><span style="font-size: 11.0pt; font-family: 'Arial',sans-serif; color: #333333;"><br />- </span><span style="font-size: 11.0pt; font-family: 'MS 明朝',serif; color: #333333;">ラインマネージャーとしての職務経験</span></p>

Job posted: 2021-12-10

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