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■職務概要

ICF LeadとしてICFのレビューやQ＆Aの作成、ICFの作成から依頼者承認までの手順の構築、スケジュール管理、翻訳などICFに関するマネジメントを行います。また、顧客および社内他部門と協業する際の窓口としても機能し、Site Start-upチーム（Clinicalも含む）のICFに関する業務をリードします。

■職務詳細

・合意された治験届戦略に従い、プロジェクトのタイムラインを遵守しながら、担当プロジェクトのStudy Master ICF/Country ICF作成の管理・監督およびレビュー・承認・エスカレーションを行う。

・合意されたサイトアクティベーション戦略に従い、プロジェクトのタイムラインを遵守しながら、担当プロジェクトのSite ICFの作成の管理・監督およびレビュー・承認・エスカレーションを行う。

・依頼者や社内の Globalチームと協業し、Study Master ICF/Country ICFの完成までのプロセスを策定する。

・ICF Writer並びにICF Leadに割り当てられた予算の管理・調整。

・各部門（薬事、法務、CO、PM、MD等）やスポンサーと協力してStart-up phaseにおけるICF特有について検討、対応を行う。

・社内又は依頼者のICF Templateの作成及び管理をする。

・ICFに関するSOPやツールの作成及び管理をする。

・ICFに関する社内教育の実施及び相談窓口を行う。

・部門内および他部門との協力によるICFに関するプロセス改善活動を促進する。

・必要に応じ経験の浅いメンバーやICF Writerのメンター、コーチを担う。

・必要に応じ、顧客や社内チームに対しプレゼンテーションやトレーニングを実施する。

At a global level, drive Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines to develop the informed consent form (ICF), including during the maintenance phase.

Experienced professional individual contributor who works under mimimum supervision. May mentor or otherwise help newer team members navigate processes. Responsible for making adjustments or recommended enhancements in systems and processes to improve performance of job area. Problems faced are predominantly routine though occasionally non-routine.

Essential Functions

As an ICF lead, you will be responsible to oversee the overall processes of ICF development and associated project/study team activities:

• Manage / author development and roll out of project instructions (global and country), templates, and supporting documentation including training materials to enable ICF development at master / country level

• Partner key client accounts in the ICF development

• Coordinate the implementation of changes to developmental processes and documentation when global / regional regulations impacting multiple countries arise

• Implementation / roll out of ICF changes when new / revised ICF templates and guidelines are generated

• Review, establish and agree on project planning and project timelines with sponsor and team

• Review Patient Informed Consent Form (ICF) for completeness and accuracy

• Verify ICFs against the study protocol

• Distribute reviewed core level ICFs to ICF Specialists within country site activation

• Review, track and follow up the progress, the approval and execution of ICF documents

• Review country level ICFs and adjust in accordance with study specific requirements

• Review and provide feedback to management on the project status

• Communicate key changes in these documents to a Sponsor

• Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project specific information

• Support team of ICF specialists in resolving their enquiries and provide cross-functional training and support as required

• Act as a point of escalation within the project or at a client level

Qualifications

• Experience with ICF writing

• 3 years of clinical research experience in similar role at minimum or equivalent combination of education, training and experience is required.

• Ability to build strong relationships with stakeholders is essential, experience in sponsor facing role is strongly preferred

• Ability to lead the team on assigned projects

• Good analytical and organizational skills

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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