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Clinical Data Manager

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Location
Japan-Tokyo
2 hit(s)  

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Responsibilities:
Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities
• Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data
• Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts
• Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics
• Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications
• Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions
• Coordinate the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities
• Advanced planning and risk management for projects (issue escalation, resource management)
• Support recruitment of new data management candidates
• Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality
• Supervise, mentor and evaluate performance of data managers in the location and aide in staff development, career development, interpersonal skills, and achievement of competency standards
• Support the technical mentoring of data review staff in regional locations and aide in staff development, career development, interpersonal skills, and achievement of competency standards
• Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget
• Maintain technical data management competencies via participation in internal and external training seminars
• Ensure project staff are trained and adhere to project-specific, global, standardized data management processes
• Identify areas for process and efficiency improvement and implement solutions on assigned projects
• Support achievement of project revenue and operating margin for data management activities to agreed targets
• Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary
• Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
• Review literature and research technologies/procedures for improving global data management practices
• Perform other duties as assigned by management.

Requirements:
University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
• Additional relevant work experience will be considered in lieu of formal qualifications
• Broad knowledge of drug development process
• Understanding of global clinical development budgets and relationship to productivity targets
• Thorough knowledge of effective clinical data management practices
• Thorough knowledge of time and cost estimate development and pricing strategies
• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing

Experience:
Minimum six (6) years relevant work experience in data management with approximately three (3) years technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
• Demonstrated skill for technical management of staff exceeding 10 employees.
• Financial management of gross revenues in excess of $500K per year
• Excellent oral and written communication and presentation skills.
• In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
• Demonstrated ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions
• Demonstrated managerial and interpersonal skills.
Education/Qualifications
• University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
• Additional relevant work experience will be considered in lieu of formal qualifications
• Broad knowledge of drug development process
• Understanding of global clinical development budgets and relationship to productivity targets
• Thorough knowledge of effective clinical data management practices
• Thorough knowledge of time and cost estimate development and pricing strategies
• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing
Experience
• Minimum six (6) years relevant work experience in data management with approximately three (3) years technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
• Demonstrated skill for technical management of staff exceeding 10 employees.
• Financial management of gross revenues in excess of $500K per year
• Excellent oral and written communication and presentation skills.
• In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
• Demonstrated ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions
• Demonstrated managerial and interpersonal skills.
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