( 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
( 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
* Drive impactful change in rare disease medicine, overseeing study management, site relationships, and strategic planning in a supportive and inclusive remote work environment. Client Details * US-based biotech specializing in research and devlopment of innovative
Position Summary: The TA Functional Manager(FM) is accountable for strategic and operational management and successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s), including resource allocation, adherence to timelines and
Position Summary: The TA Functional Manager(FM) is accountable for strategic and operational management and successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s), including resource allocation, adherence to timelines and
The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, youll be
Position Purpose: The Clinical Compliance Operations (CCO) Manager is a position within Clinical Development Operations, R&D Japan responsible for supporting the Clinical Research & Development, Clinical Operations Tokyo and Project Management to provide therapeutically aligned compliance support to study teams focusing on adherence
Vaccine Medical Science Liaison (ワクチン・メディカルサイエンスリエゾン) The Medical Science Liaison (MSL) is a field-facing role whose main objectives are to: 1. exhibit a high degree of scientific and clinical knowledge, i.e. a robust knowledge of diseases, vaccinology, product
Job Description 1. The Senior Manager, Quality Operational Capabilities is responsible for managing local SOP, TMF plan, relevant systems/process for clinical operation, Quality oversight of clinical trial, supporting for planning and conducting global annual audit plans, and all activities
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
* Lead activities in global clinical trials, ensuring the successful planning, execution, and oversight of site monitoring activities. * Provide mentorship to less experienced staff, and foster a learning culture within the Clinical Development & Operations team, promoting continuous
Job purpose Medical Science Liaison (MSL) is a field-based role in the new Medical and Development organization, reporting to MSL Head. In order to build a trust with External Experts (EE) and scientific community through, MSL
This role as an AP Manager within the Clinical Research Industry involves managing the accuracy and timeliness of invoices from medical facilities, reporting to the headquarters in the US while enjoying unique benefits like hybrid work arrangements
Working 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.
Responsible for executing the following basic MSL tasks under the guidance of his/her superior and the support of a senior MSL. • Responsible for building trust relationship with Key Individuals (KIs) in their therapeutic area and
Responsible for executing the following basic MSL tasks under the guidance of his/her superior and the support of a senior MSL. • Responsible for building trust relationship with Key Individuals (KIs) in their therapeutic area and
International SOS is the world’s leading medical and security services company with over 12,000 employees working in 1,000 locations in 90 countries. International SOS Government Services administers the TRICARE Overseas Program providing high-quality, accessible health care
* Join our client as a Senior Associate Clinical Contracts & Budgets, where youll lead end-to-end contracting processes for clinical studies, ensuring seamless operations and payment accuracy. Fluency in Japanese is essential, along with a knack for negotiation, attention
* Create and lead Evidence Generation Plan for the Oncology portfolio * X-functional position understanding strategies of Medical / Commercial / R&D Client Details * Global pharmaceutical company * Pioneer and Leader in RWE, observational research
Working 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.