Covance

  • Clin Data Coord III

    Job Location(s) CN-Shanghai
    Job Number
    2019-34902
    Job Category
    Clinical Data Management
    Position Type
    Full-Time
  • Job Overview

    • Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management process (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.
    • Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
    • Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database.
    • Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application.
    • Perform reconciliation of the clinical and safety database.
    • Perform reconciliation of central laboratory and/or third party vendor data (eCRF, eDiary, specialty laboratory, etc.)
    • Perform aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation.
    • Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved.
    • Serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion guidelines, etc.
    • Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
    • Assist in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications.
    • Assist in the creation of data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions.
    • Assist in 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 handing and quality.
    • Serve as client contact for project meetings and CDM status updates.
    • Potentially support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
    • Support the training of project staff on project-specific, global, standardized data management processes.
    • Maintain technical data management competencies via participation in internal and external training seminars.
    • Review literature and research technologies/procedures for improving global data management practices.
    • Perform other duties as assigned by management.
    •  

    Education/Qualifications

    Minimum required:
    • 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).

    • In lieu of the above requirement, approximately 18 months experience in related field incorporating approximately 1 year’s clinical data management experience in addition to the 4 years relevant work experience in data management will be considered
    • Broad knowledge of drug development process
    • Understanding of global clinical development budgets and relationship to productivity targets
    • Knowledge of effective clinical data management practices
    • Cursory knowledge of time and cost estimate development and pricing strategies
    • Thorough knowledge o ICH guideline and GCP including international regulatory requirements for the conduct of clinical development programs.

    Experience

    • Minimum 4 years relevant work experience with increasing responsibility in data management with knowledge of 2 or more therapeutic areas.
    • Demonstrated time management skill and ability to adhere to project productivity metrics and timelines
    • Excellent oral and written communication skills and demonstrated presentation skills
    • Knowledge of clinical trial processes 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
    • Potential ability to lead by example data management staff

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