Covance

  • Clin Data Mgr I

    Job Location(s) CN-Shanghai | CN-Beijing | CN-Dalian
    Job Number
    2019-30957
    Job Category
    Clinical Data Management
    Position Type
    Full-Time
  • Job Overview

    • 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
    • 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 or certification in a related allied health profession from an appropriately accredited institution
    • Additional relevant work experience will be considered in lieu of formal qualifications
    • Broad knowledge of drug development processes
    • Understanding of global clinical development budgets and relationship to productivity targets
    • Knowledge of time and cost estimate development and pricing strategies
    • Thorough knowledge of ICH guidelines and HCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing

    Experience

    • 4-6 years relevant work experience in data management with approximately one 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
    • 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 relationship and regulatory obligation of the CRO industry with pharmaceutical/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 solution
    • Demonstrated managerial and interpersonal skills

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