北京招聘

职位描述：
*Responsibilities/Duties
? 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 I diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion I monitoring conventions
? Coordinate the development and testing of data management system edit/ data validation checks (diagnostics) and special listings I procedures used as tools for the data review and discrepancy management activities
? 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
? Advanced planning and risk management for projects (issue escalation, resource management)
? Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget
? Assist with goal creation and performance review assessment for data review project staff
? 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.
*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 globaJ clinical development budgets and relationship to productivity targets
? Knowledge of effective clinical data management practices
? Knowledge of time and cost estimate development and pricing strategies
? Thorough knowledge ofiCH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing
*Experience
? Minimum five (5) years relevant work experience in data management with approximately one ( 1) year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
? Demonstrated skill for technical management of staff exceeding 5 employees.
? Financial management of gross revenues in excess of $250K 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 I biotechnological companies.
? 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 manageriaJ and interpersonal skills. 举报 分享

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