Tokyo The businesses of Merck KGaA, Darmstadt, Germany Full time

メルクと一緒に、あなたの力を発揮しよう  
 
冒険、限界への挑戦、そして発見に焦がれるあなたへ。あなたの大志を、メルクで羽ばたかせましょう科学とテクノロジーを駆使したイノベーションに情熱を注ぐメルクのスタッフは世界中で活躍中です。ヘルスケア、生命科学、エレクトロニクスの分野で、メルクのソリューションは人々の暮らしをますます豊かなものにしています。あなたとメルクの力を合わせて、大きな夢を抱きましょう。メルクは、人、顧客、患者、そしてこの地球という惑星が共存する豊かな世界の構築に情熱を注いでいます。このためメルクでは、好奇心にあふれた人材を募集中です。メルクと一緒に、想像を超えた世界を開拓しませんか?  

患者さんのためにひとつになって団結し、生命の誕生、QOLの向上、命をつなぐサポートをすることか、ヘルスケアにおける私たちの目的です。私たちは、腫瘍学、神経学、不妊治療などの疾患領域において、医薬品、インテリジェント装置、革新的技術を開発します。私たちのチームは、人生のすべてのステージで患者さんを助けるために、情熱と執拗な好奇心を持って6大陸全体で協力して働いています。ヘルスケアチームに入ることは、多様的で包含的、そして柔軟な職場文化の一部となることです。世界中で個人的な能力開発とキャリアアップの素晴らしいチャンスが待ち受けています。

YOUR ROLE

 

As a Country Study Start-up Manager, you will play a pivotal role in overseeing the timely and quality completion of clinical trial activities up to site activation. Your key responsibilities will include managing local and central ethics committee submissions, ensuring the collection and preparation of essential documents, and acting as the primary contact for study sites to facilitate smooth regulatory communications. Additionally, you will proactively identify potential risks or delays and develop strategies to mitigate these issues, ensuring that the site activation process aligns with our company's mission to accelerate the delivery of innovative therapies to patients. This role's purpose is to address the challenges of timely site readiness, contributing to our vision of bringing medicines to patients faster.

 

WHO YOU ARE

  • 3-5 years of relevant experience in clinical trial start-up processes.
  • Strong knowledge of regulatory requirements and ethics committee submissions.
  • Excellent communication skills, both verbal and written, in English.
  • Proven ability to manage multiple projects and priorities effectively.
  • Familiarity with document management systems such as Veeva, SharePoint, CTMS, and eTMF.
  • Adaptability and flexibility in a fast-paced, high-volume environment.
  • Strong problem-solving skills and a proactive approach to challenges.
  • Ability to work independently and collaboratively within a multicultural team.

  • 私たちが提供するもの:私たちは、さまざまな背景、視点、人生経験を持つ好奇心旺盛な人々で構成されるグループです。この多様性が卓越性と革新を促進し、科学と技術のリーダーシップを強化すると信じています。私たちは、すべての人が自分のペースで成長し発展するためのアクセスと機会を創出することにコミットしています。何百万もの人々に影響を与え、誰もが人類の進歩を支持できるようにする包括性と帰属感のある文化を築くために私たちに参加してください

    今すぐ応募して、発見を促し、人類の発展を高めることに専念するチームの一員になりましょう



    • Tokyo The businesses of Merck KGaA, Darmstadt, Germany Full time

      As a Country Study Start-up Manager you will play a pivotal role in overseeing the timely and quality completion of clinical trial activities up to site activation. · ...


    • Tokyo, Tokyo Merck Healthcare

      We are seeking a Country Study Start-up Manager to oversee the timely and quality completion of clinical trial activities up to site activation. · Managing local and central ethics committee submissionsE nsuring the collection and preparation of essential documentsActing as the p ...


    • Japan BeiGene

      We are looking for a Study Start-up Specialist to lead the delivery of study start-up activities including initial and ongoing submissions within established timelines with high quality. · ...


    • Tokyo, Tokyo Planet Pharma

      This role sits within Clinical Operations Excellence and acts as a local subject matter expert for Study Start-Up (SSU) activities. · ...


    • Tokyo Amazon Full time

      Amazon Logistics (AMZL)はAmazonのラストマイル輸送を管理し、お客様に高品質で魅力的な配送サービスを提供する使命を担っています。プランニング・エンジニアリング・テクノロジー・プロジェクトマネジメントなどの多彩なチームが、最終配送拠点であるDSやアマゾンロジスティクスパートナーズロジスティクス(AMPL)のメンバー、あるいは外部の配送企業と連携してオペレーションを遂行しています。またグローバルチームと連携しながら、Amazon独自のテクノロジーを駆使した画期的な配送プログラムを戦略的に展開しています。Launch and Expa ...


    • Tokyo Amazon Full time

      Amazon Logistics (AMZL)はAmazonのラストマイル輸送を管理し、お客様に高品質で魅力的な配送サービスを提供する使命を担っています。拠点立ち上げ時はオペレーション部門と採用計画作成から協働し、現場を作り上げ運用開始後の生産性向上まで並走します。 · ...


    • Chiyoda Johnson & Johnson Innovative Medicine

      A Lead Local Trial Manager or Senior Local Trial Manager is responsible for local management of a clinical trial in a country or countries. · ...


    • Chiyoda Johnson & Johnson Innovative Medicine ¥3,600,000 - ¥12,000,000 per year

      A Lead Local Trial Manager is considered as a senior trial management role with at least 4 years of clinical trial management experience or more than 6 years of clinical monitoring experience. · ...


    • Tokyo Amazon Full time

      · Amazon Logistics (AMZL)は Amazon no rasuto mairi yusan wo kanri shite, okyaku ni koutai teki na hinkyuu taisho service wo tasuke wa ningen no misyon ga arimasu. Rasuto kosuto no seikouka to raisutei speed no koujou ni tsuite umarete irushita deiri basutingu o fukugen surutenin ...


    • Chiyoda Johnson & Johnson Innovative Medicine Full time

      A Lead, Local Trial Manager is considered as a senior trial management role with at least 4 years of clinical trial management experience or more than 6 years of clinical monitoring experience. · ...


    • Chiyoda Johnson & Johnson Innovative Medicine

      We are seeking individuals who demonstrate responsibility, enthusiasm, and the ability to take initiative—those who can adapt to change, learn proactively, and embrace new challenges—as prospective candidates in our global leadership development program (LDP). An Associate, Site ...


    • Tokyo Abbott Laboratories Full time

      This role is responsible for managing study documentation and operational progress using Clinical Trial Management System, · Ensure compliance with clinical protocol and applicable regulatory requirements such as GCP, ISO14155 or GPSP through appropriate management, review, and m ...


    • Tokyo Bayer Full time

      Leads the creation of the strategic global medical plan for Pharma Therapeutic Area product in alignment with countries' medical planning and global business function. · Liaises with key opinion leaders to support commercial success of Bayer Pharma products. · ...


    • Tokyo The businesses of Merck KGaA, Darmstadt, Germany Full time

      As a Senior Clinical Research Associate you will play a critical role in the management of clinical trials across multiple protocols and therapeutic areas ensuring participant safety and data reliability contributing to our mission of advancing healthcare innovation. · ...


    • Tokyo Abbott Laboratories Full time

      Clinical Affairs: Clinical Project Manager · Job summary · A clinical project manager provides leadership to plan, prepare and execute high quality large scale and/or complex clinical programs. · ResponsibilitiesResponsible for several (possible global) clinical trialsResponsible ...


    • Tokyo Medtronic Full time¥15,000,000 - ¥25,000,000 per year

      At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. · Oversees, designs, plans and develops clinical evaluation research studies. · ...


    • Tokyo Amazon Full time

      For those who want high ownership, real decision-making authority, and the opportunity to drive large-scale, complex projects, L&E offers an environment rich with challenge and growth. · ,Bachelor's degree or above 5+ years of project management experienceConversational,written c ...


    • Tokyo Amazon Full time

      We are seeking a Senior Product Manager, Tech Service Offering to develop and scale our SAS business launched in 2020. · ...


    • Tokyo Amazon Full time

      eero is the first company to deliver a whole home WiFi experience using mesh technology. · eero's mission is to design and deliver hardware and software that anticipates our needs, takes care of us and our families, keeps us safe and healthy, and saves money and energy. · The Sen ...


    • Tokyo Amazon Full time

      We are looking for a Partner Marketing Manager to help drive awareness and adoption of our apps and services with our 3rd party games/apps. You will be an advocate for our app developers and our customers and create friction-less experiences for them.You will own the strategy and ...


    • Japan Novotech

      This role provides supervision leadership and line management of the Regulatory team ensuring that line reports are trained and managed to regulatory process including RA approval according to ICH-GCP guidelines local regulatory requirements Novotech client standard operating pro ...