Senior Clinical Data Manager 

     

YOUR TASKS AND RESPONSIBILITIES:

Role Overview
The Data Management Expert serves as a key subject matter expert in data management activities, particularly in early clinical development phases. Responsibilities include vendor management, mentoring staff, leading working groups, and presenting best practices at industry events.

• Data Management Expertise
  • Act as the primary expert on data management processes in early clinical development
  • Mentor junior staff and train team members
  • Lead expert working groups and present at industry meetings
  • Participate in vendor selection, management, and due diligence assessments
• PDM/EPDM Tasks
  • Govern the use of data management standards across studies
  • Develop and maintain Medical Standards and data structure standards
  • Ensure adherence to Data Management Best Practices and SOP compliance
  • Oversee outsourcing activities, including budget input and vendor management
  • Advise on resource planning based on clinical activity forecasts
  • Facilitate smooth project transitions between research and development phases
  • Support data-driven processes across interfacing business functions
• SDM Tasks
  • Serve as Study Data Manager for internal and outsourced studies
  • Ensure accountability for CDM deliverables from protocol creation to data release
  • Manage risk identification and mitigation in data management plans
  • Document all activities according to SOPs and lead quality control efforts
  • Develop study-specific eCRFs and data consistency checks
  • Prepare and implement standard plans for data management governance
  • Engage in ongoing data review and reconciliation activities
• Additional Responsibilities
  • Establish data management best practices for research activities
  • Demonstrate Dynamic Shared Ownership and independent project management
  • Embrace and integrate new technologies to improve data management efficiency
• Compliance
  • Ensure compliance with SOPs, GCP, and ICH guidelines
  • Maintain accurate and timely documentation for all projects

WHO YOU ARE:

• Bachelor's degree (or equivalent/higher), preferably in the fields of Natural Sciences, Life Sciences, Informatics, Medical Documentation or related subject 
• Experience: 2-5 years in study/project-level data management, with at least 2 years as a Study Data Manager or equivalent in a scientific, data-driven role within medical research
• Experience in pharmaceutical companies or CROs is preferred
• Knowledge: Strong understanding of the drug development process and relevant research methodologies
• Technical Proficiency: Familiarity with data management methodologies and technologies, including Electronic Data Capture, data warehousing, and SAS
• Regulatory Knowledge: Understanding of ICH, GCP, European Clinical Trials Directive, and privacy regulations (e.g., HIPAA).- Good understanding of the drug development process, understanding of relevant research processes
• Detail-Oriented: Ability to execute data management activities independently with precision
• Leadership: Capable of leading a Clinical Data Management (CDM) team and contributing to project-level activities
• Collaboration: Strong organizational skills with the ability to work effectively in a global environment and collaborate with minimal supervision
• Customer Focus: Demonstrates a commitment to customer satisfaction and drives results
• Planning & Alignment: Effectively plans and aligns project activities
• Interpersonal Skills: Instills trust and manages complexity in team dynamics
• Fluency in Japanese and English is required for the role 

WHAT BAYER CAN OFFER YOU:

• We offer a competitive a salary package consisting of an annual basic salary and Short-Term Incentive (STI) bonus and top performance award and so on, tailored to your role at Bayer
• We provide various special paid day-offs on top of given annual paid vacation days. Also, we promote work-life balance by offering employees flexible working hours and home-office arrangements depending on your job nature in alignment with your manager
• We support your professional growth by providing learning and development opportunities through training programs, regular feedback and project participations
• At Bayer, our employees are welcomed, supported, and encouraged to reach their full potential. We also embrace and respect diversity by providing an inclusive and fair work environment for all employees
• We provide various attractive corporate benefit programs for all of our valuable employees such as DC pension plan, health and medical support by Bayer Health Insurance Association, Benefit Club membership, and life insurance

    採用予定日:ASAP   部門:医療用医薬品  勤務地:大阪または東京 職務領域:情報技術  ポジションの職務等級:VS1.1~VS1.2 (経験による)   社員区分:正社員  勤務時間:09:00 - 17:30    連絡先 E-Mail       

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