- 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
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R&D, Clinical Research Associate(CRA)/Site Manager, Global Clinical Operation Japan
次の場所にあります: beBee S2 JP - 4日前
Johnson & Johnson Chiyoda City, 日本 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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Non-Clinical Expert
次の場所にあります: Talent JP C2 - 4日前
Novo Nordisk Chiyoda City, 日本Do you have a strong background in non-clinical activities? We are looking for a Non-Clinical Expert to join our team at Novo Nordisk. If you are ready to contribute to the development, submission, and approval of new drugs/devices, and have a passion for maintaining existing pro ...
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R&D, Senior Site Contract Manager, Contract and Centralized Services
次の場所にあります: beBee S2 JP - 4日前
Johnson & Johnson Chiyoda City, 日本 OTHERPosition Summary: · Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organizatio ...
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Personal Assistant
次の場所にあります: Talent JP C2 - 3日前
Novo Nordisk Chiyoda City, 日本Are you a detail-oriented and organized individual? Do you thrive in a fast-paced environment? We are currently seeking a Personal Assistant to join our Diabetes Business Unit (DBU) at Novo Nordisk Japan. If you are prepared to offer essential support to our management team and c ...
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Senior Manager, Operation Manager
次の場所にあります: beBee S2 JP - 5日前
Bristol Myers Squibb Chiyoda City, 日本 OTHERWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
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React】Frontend Application Engineer VISA support available JLPT N2 UP or Chinese Welcome
次の場所にあります: beBee S2 JP - 4日前
151A NEIGHBORS Chiyoda City, 日本 フルタイムJob Requirements · Required English Level: Conversational Level · Required Japanese Level: Business Level · Current Residence Requirement: Japan · Visa Sponsorship: Yes · *Someone with JLPT Level 2 Japanese language ability or higher(MUST be able to adequately communicate in the ...
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Specialist, Scheduling and Cell Logistics
次の場所にあります: beBee S2 JP - 5日前
Bristol Myers Squibb Chiyoda City, 日本 OTHERWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
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Senior Manager, Corporate Affairs
次の場所にあります: beBee S2 JP - 6日前
Bristol Myers Squibb Chiyoda City, 日本 OTHERWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
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Senior Manager Taxation, AsiaPac
次の場所にあります: beBee S2 JP - 6日前
Bristol Myers Squibb Chiyoda City, 日本 OTHERWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
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Senior Specialist Regional Payroll
次の場所にあります: beBee S2 JP - 6日前
Bristol Myers Squibb Chiyoda City, 日本 OTHERWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
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SrAssociat QualityAssurance
次の場所にあります: Talent JP C2 - 4日前
Pfizer Aichi Prefecture, 日本 フルタイムWhy Patients Need You · 私たちの日々の業務はすべて、製品品質と患者さんへの安全で効果的な製品の提供に対する揺るぎないコミットメントに則したものです。私たちの科学的でリスクに基づく品質文化は、柔軟性があり、革新的で、顧客志向なものです。研究開発に関わっているかに関係なく、品質文化に対するあなたの貢献が患者さんに直接影響を与えることができます。 · Everything we do, every day, is in line with an unwavering commitment to the quality and the d ...
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品質オペレーションズ部 サイトコンプライアンス課 一般社員/Staff, Site Compliance, Nagoya QO
次の場所にあります: Talent JP C2 - 4日前
Pfizer Aichi Prefecture, 日本 フルタイムWhy Patients Need You · 私たちの日々の業務はすべて、製品品質と患者さんへの安全で効果的な製品の提供に対する揺るぎないコミットメントに則したものです。私たちの科学的でリスクに基づく品質文化は、柔軟性があり、革新的で、顧客志向なものです。研究開発に関わっているかに関係なく、品質文化に対するあなたの貢献が患者さんに直接影響を与えることができます。 · Everything we do, every day, is in line with an unwavering commitment to the quality and the ...
R&D, Local Trial Manager, Oncology Clinical Operation - Chiyoda City, 日本 - Johnson & Johnson
説明
[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
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.
