[Innovative Medicine] R&D, Local Trial Manager, Oncology Clinical Operation
Veröffentlicht:
20 August 2024Pensum:
100%Vertrag:
Festanstellung- Arbeitsort:Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
[ 概要]
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。
[ 具体的な業務例]
・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.