« top | メイン




【新着求人情報】 ・・・ MNT-01公開しました。

状況 求人No 資本金 勤務地 スペック 英語力
NEW  MNT-01 22.73億 外資 東京 Senior CRA in Oncology Clinical Operations
・The senior Clinical Research Associate (Sr .CRA) is accountable and responsible for Country Lead Monitor for assigned oncology studies. The CLM leads assigned Japan local monitoring team and works in close collaboration with global study team. The Sr CRA all aspect of site management and monitoring activities for assigned applicable Phase I and all Phase II -IV clinical investigator sites as CLM. These global, complex studies are conducted with the standards set by Bayer Global Development, according to Good Clinical Practices (ICH-GCP) and applicable regulatory and legal requirement.
・Managing investigator sites and site activities and monitoring site data, to ensure patient safety and ethical and regulatory compliance necessary to provide quality data required for global regulatory submissions for approval of drugs.
・Managing investigator sites to ensure the investigator and site staff meet all aspects of study delivery and commitments to make certain the operational study execution is on track from site selection to site close out.
University Degree or above
・At least 5 years clinical operations experience in the pharmaceutical industry and at least 1-2 years clinical operations experience in the Oncology Field
・At lease 2 years of clinical trail/study management as a leader experience preferred.
※The incumbent is responsible for management of Phase II-IV complex and global/Local clinical trials.
・This requires an in-depth knowledge of oncology field, Good Clinical Practices (GCP), federal reg
・Fluency in Japanese, English TOEIC 730 and above
・Ensuring accountability and consistently achieving results, even under tough circumstances.
・Recognizing the value that different perspectives and cultures bring to an organization.
・Planning and prioritizing work to meet commitments aligned with organizational goals.
・Stepping up to address difficult issues, saying what needs to be said.
  MNT-02 263.49億 外資 東京 CRA
Manage clinical site of oncology trial. (site selection, site initiation, site close-out activities)
  MNT-03 4億 外資 東京 Senior Clinical Research Associate (Training Specialist)
・To enable**’ s emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of SMM deliverables involving start­up, execution, and close­out of studies.
・Strategic support role aiming to identify training needs, enhance, standardise, and facilitate training solutions for Site M&M Monitors globally
・Optimize and standardise process and materials for new hire onboarding and training across countries and regions
・Support the Country/Region / Area Heads, line managers, and mentors mentors to provide a consistent best-practice approach to onboarding
・Develop the training plans and for all Monitoring roles (e.g., new hire, inexperienced and experienced)
・Coordinate with SME’s and trainers to ensure training materials are available for CRA’s when needed. ・Ensure relevant trainings on new initiatives and activities are incorporated into the training plans
・Consolidate ‘lessons learned’ across other areas (e.g., quarterly forums, including CAPA’s etc.) and regularly incorporate these into the CRA training materials.
・Identify, address, and include Country or Region specific Clinical requirements and differences into training plans and materials as applicable
・Ensure that training plans and optimised materials / tools are housed in Development University, and drive awareness / utilisation of Development University as the online repository for CFO on a functional level.
・Develop and enhance collaboration and alignment with the Global Clinical Training function
・Identify and leverage skills and knowledge of Functional, Regional, or Country based resources (e.g, GMA, Commercial, TA Leads, CPD, GCT etc) to ensure that Site M&M personnel receive training on all areas affecting our business (e.g., Therapeutic Area training, Systems, Regulatory processes, Tools etc.) where they may not have do no have expertise themselves.
・Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
・Site Monitoring Experience: Minimum 3 years.
・Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making
・Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player.
・Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
  MNT-04 82.52億 国内 大阪 CRA(臨床開発モニター)
  MNT-05 113.4億 外資 東京 Site Monitor
・逸脱発生時の再発防止策を検討し、適切に記録(issue report、follow-up letter、モニタリング記録等)を作成する。
・組織内で求められるワークキンググループ、タスクフォース、SME(Subject Matter Expert)に貢献する。
  MNT-06 10億 外資 東京 Clinical Research Associate (CRA)
管理職候補(Study Leader候補)として、リーダーシップを発揮し、以下の業務をご担当いただける方を求めています
・その他、Japan Clinical Trial Team Memberとしての活動
・治験実務あるいはモニタリング業務経験 3年以上を目安とする
・Global Processに基づく治験実務担当経験
・少なくとも英語での読み書きができる(目安としてTOEIC 650点以上)
  MNT-07 4億 外資 東京 Site Clinical Research Associate
Primary Goals/ Objectives
?Monitors activities conducted by clinical investigative sites as they relate to ** clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity. ?The Site Clinical Research Associate (SCRA) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring ** studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites. Education
?Bachelor’s Degree required; medical/science/nursing background is preferred.
Background (Experience)
?Minimum of 1 year of clinically-related experience, of which a period of 6 months is preferable in clinical research monitoring.
?Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
?Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
?Experience in on-site monitoring of investigational drug or device trials is required.
Required Functional Competencies
?Demonstrated strong site management and monitoring skills.
?Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
?Good written and verbal communication skills. Written and verbal fluency in English and local language (if not English).
?Acute observational skills, analytical and conceptual capabilities.
?Exhibits high degree of flexibility when facing changes in the work environment.
?Attention to detail and strong interpersonal skills.
?Competence in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications.
?Previous experience with electronic data capture systems is desirable.
?Ability to work independently with minimal supervision.
?The SCRA anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action as indicated. The SCRA should use functional expertise and exercise good judgment in seeking appropriate guidance and ensures that follow-up to any and all corrective action is taken at the clinical site and is properly documented.
Good written and verbal communication skills. Written and verbal fluency in English and local language (if not English)