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> 【IQVIA】ICF Specialist ★ほぼフルリモート★（医薬品－臨床）に関連した業務経験を活かせるポジション

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【IQVIA】ICF Specialist ★ほぼフルリモート★（医薬品－臨床）に関連した業務経験を活かせるポジション

年収：応相談

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部署・役職名	【IQVIA】ICF Specialist ★ほぼフルリモート★（医薬品－臨床）に関連した業務経験を活かせるポジション
職種	非臨床研究臨床開発 CRA（臨床開発モニター）
業種	その他 CRO
勤務地	東京都大阪府福岡県
仕事内容	Overview: 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 minimal 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
労働条件	リモートワークメイン
応募資格	【必須（MUST）】 • Business level English • Experience with ICF writing • 3 years of clinical research experience in similar role at minimum or equivalent combination of education, training and experience • Ability to build strong relationships with stakeholders • Ability to lead the team on assigned projects • Good analytical and organizational skills 【歓迎（WANT）】 • Business level English (Speaking) • Experience in a sponsor facing role
アピールポイント	外資系企業女性管理職実績あり年間休日120日以上産休・育休取得実績あり教育・研修制度充実
リモートワーク	可「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります
受動喫煙対策	その他「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」などの場合がその他となります。面接時に詳しい内容をご確認ください
更新日	2024/09/12
求人番号	3871363

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