( 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
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
Job Description Job Title: Systems Administrator Reporting to Manager, PSG IT Location: 1-12-10 Shinkiba, Koto-ku, Tokyo 136-0082, Tokyo, Japan Division Specific Information: PSG CTD Tokyo Position Summary You will contribute as a member of the PSG
Established in 1996, it has grown year over year to more than 850 people worldwide. It provides commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical
Details about the Client Our client is a global leader in health technology, focused on improving peoples lives through meaningful innovation. With a diverse portfolio spanning healthcare, medical device, and consumer lifestyle products, our client is
* Lead and manage a team of biostatisticians and data managers to ensure the delivery of high-quality and timely statistical analysis plans, data management plans, and data analyses for clinical trials. Client Details * Our client
* Contribute to the development of innovative cancer therapies by working collaboratively with R&D, program management, clinical operations, biostatistics, and data management teams * Contribute to the clinical strategy and development plans for various oncology indications
[ Your Future Company ] Bokksu is a venture-backed, trailblazing direct-to-consumer brand that delivers artisanal Japanese snacks to happy snackers in 100+ countries. Were proud to partner directly with centuries-old family snack makers in Japan to
GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people worldwide.
Manage Safety staff responsible for Safety Operations processing in alignment with departmental and corporate standards. Contribute to Global initiatives. Work in close collaboration with SM and other relevant stakeholders supporting the achievement of local and global
Work Flexibility: Hybrid or Onsite Position summary: Work as part of the Network Services Integration team to deliver network infrastructure projects in line with identified requirements. Work with key stakeholders to ensure that all deliverables are
