日本国内で治験を実施するためのオペレーションチームリーダーとして、国内外のステークホルダーとの協議
- 交渉など、エキスパートとしてのコミュニケーションを通じ、品質を確保した臨床試験を計画通りに遂行する。
- 試験実施施設の選定戦略、症例組み入れプラン
- 戦略の作成及び実行
- 試験遂行のための現場の責任者としてモニターへの指示及びモニターへの助言
- 試験全体の進捗およびGCP,SOPに沿った臨床試験の実施と品質の確保
- 国際共同試験の場合、海外担当者からの指示の正確な把握及び協議を含めた円滑なコミュニケーション
- 試験におけるRisk & Issue Management
- 治験契約締結交渉、データ固定、GCP
- SOPに基づくモニタリングに対するモニターへのフォロー
- チームビルディング、ステークホルダーマネジメントによるチーム作り
- 社内の改善活動 / Task force teamへの参加
- 試験全体の予算の管理
Position Summary:
The Local Trial Manager II (LTM II) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries.
The LTM II is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents.
The LTM II is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
The LTM II actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and LTM I roles.
The LTM II may have some site management responsibilities.The LTM II may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for single country as described in GCO procedural documents.
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Chiyoda City Johnson & Johnson OTHER[概要] · 治験の実施に関わる施設選定~データベースロック/治験終了までのモニタリング業務 · [具体的な業務例] · • 治験契約締結交渉 · • 初回IRB申請手続き · • 施設セットアップ、医療関係者トレーニングの実施 · • 症例登録促進活動の実施、GCP · • SOPに基づくモニタリング · • 治験の質的管理、原資料等の直接閲覧/症例報告書のSDV実施 · • 施設における治験費用の管理 · • その他、社内のImprovement activity / Task force teamへの参加 · Position S ...
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