Clinical Team Lead- FSP

<h2>Job Overview:</h2><p style="margin: 0in 0in 0pt;"><strong><span style="color: black; font-family: 'Tahoma',sans-serif; font-size: 10pt;">Clinical Team Lead</span></strong><span style="color: black; font-family: 'Tahoma',sans-serif; font-size: 10pt;"> is responsible for execution, monitoring, and controlling of the clinical trials from operational side. You will also be involved with budgeting, participation of bid defense, and planning of projects. </span></p><p style="margin: 0in 0in 0pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"> </span></p><p style="margin: 0in 0in 0pt;"><strong><u><span style="color: black; font-family: 'Tahoma',sans-serif; font-size: 10pt;">Responsibilities</span></u></strong></p><p style="margin: 0in 0in 0pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Commercial Responsibilities</span></p><ul><li style="color: black;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Contribute to the operational plan and participate in the delivery of Bid Defense presentations for new business, as required.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"> Develop and maintain relationships with assigned clients and serve as the client interface for all clinical operations matters. Meet/exceed client satisfaction expectations.</span></li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt; margin-top: 0in; margin-bottom: 0pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Initiation and Planning</span></li></ul><ul><li style="color: black;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Sets the project related clinical operations objectives and strategy in collaboration with the Core Team.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Provide input into the development of feasibility materials and recruits potential investigators. Responsible for the final site list.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Requests, manages and tracks clinical project resource needs.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Provides clinical operations input into cross functional project plans.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Develops the risk and contingency plans for key clinical operations activities in collaboration with the Core Team.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Manages the successful design, implementation, tracking and revision of the monitoring plan and clinical operation training plans for assigned projects.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Writes the prototype informed consent form.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Provides clinical support to Global Site Services for regulatory submissions and IRB/ERC queries.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Assists in the design of the CRF, EDC or equivalent.<br />Owns the development of project-specific site and monitoring tools.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Owns the development of training materials and training specific to the clinical operations team.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Develops and presents the clinical operations training materials for Investigator Meetings.</span></li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt; margin-top: 0in; margin-bottom: 0pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"> Execution</span></li></ul><ul><li style="color: black;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Responsible and accountable for management of the Clinical Operations team with particular emphasis on teamwork, quality and compliance with the project plans.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Responsible and accountable for the clinical operations budget for the project. Ensures that clinical operations activities are within budget and scope.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Responsible for managing the clinical operations timelines as agreed with the client.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Participate in internal project review meetings and provides clinical operations updates to the project management team.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Responsible for the clinical management of approved sub-CROs. May also be requested to manage approved vendors for clinical activities or services.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Ensures that all clinical operations staff allocated to assigned projects adhere to professional standards and SOPs.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Ensures appropriate utilization of all assigned clinical operations team members.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Responsible for timely and appropriate communication to the clinical operations team.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Provide performance feedback of team members to respective supervisors.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Ensure accurate and timely trip report completion and trip report review.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Review and approve investigator grant payments</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Follow project issue escalation process and Labcorp’s Corrective Action Issue Resolution (CAIR) process for clinical operations issues.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Responsible for clinical operations Corrective and Preventative Action plans.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Performs co-monitoring visits when necessary.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Ensure timely filing of relevant sections of the TMF.</span></li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt; margin-top: 0in; margin-bottom: 0pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Monitor and Control</span></li></ul><ul><li style="color: black;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Track client project metrics related to the clinical operations deliverables.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Owns and implements the risk and contingency plans for key clinical operations activities.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Coordinate activities and review progress of the clinical operations aspect of projects and initiate appropriate actions to achieve target objectives.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Track project progress against financial milestones using applicable financial systems. Review Time Analysis and provide monthly hours forecast.</span></li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt; margin-top: 0in; margin-bottom: 0pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Close-Out</span></li></ul><ul><li style="color: black;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Consolidates resources to ensure financial viability during close-out.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Ensures all site issues have been resolved.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Ensures clinical operations sections of the TMF are complete.</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">Coordinates archival of the clinical operations sections of the TMF.</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="color: black;"><span style="color: black; font-family: 'ＭＳ ゴシック'; font-size: 9pt;">ビジネスレベル以上の英語、日本語スキル（読み書き、会話）</span></li><li style="color: black;"><span style="color: black; font-family: 'ＭＳ ゴシック'; font-size: 9pt;">CTL（もしくはそれに相当する役割）として、クリニカルチームのマネージメントを行った経験</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'ＭＳ ゴシック'; font-size: 9pt;">学士資格（薬学、医学、生物科学、看護などの分野尚可）</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'ＭＳ ゴシック'; font-size: 9pt;"><span>4年以上のCRA経験</span></span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'ＭＳ ゴシック'; font-size: 9pt;">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></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">ICH-GCP/J-GCP(Good Clinical Practice) </span><span style="color: black; font-family: 'ＭＳ ゴシック'; font-size: 9pt;">の知識</span></li></ul><h2>Experience:</h2><ul><li style="color: black;"><span style="color: black; font-family: 'ＭＳ ゴシック'; font-size: 9pt;"><span>4年以上の医薬品臨床開発の知識と経験</span></span><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"> (</span><span style="color: black; font-family: 'ＭＳ ゴシック'; font-size: 9pt;">モニタリング、プロジェクトマネジメント</span><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">)</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;">SAE</span><span style="color: black; font-family: 'ＭＳ ゴシック'; font-size: 9pt;">対応経験</span></li><li style="color: black; font-family: 'Verdana',sans-serif; font-size: 9pt;"><span style="color: black; font-family: 'ＭＳ ゴシック'; font-size: 9pt;">薬事関連の知識</span></li></ul>