• Lead Clinical Data Manager, Biomarkers

    Job Location(s) US-NC-Research Triangle Park | US-PA-Philadelphia | US-PA-King of Prussia | US-NJ-Princeton | US-TX-Austin | CA-ON-Toronto | CA-ON-Mississuaga | US-IL-Chicago | US-MO-Kansas City
    Job Number
    Job Category
    Clinical Data Management
    Position Type
  • Job Overview

    Lead Clinical Data Manager, Biomarkers

    permanent, salaried

    Remote from anywhere in the U.S. or Canada


    Job Summary

    • Data management leadership on a large / global project, or multiple projects with responsibility for the development of the project Data Management Plan; data management systems set-up; and data accession, data entry and data review specifications and processes; and oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project timelines and budgets.
    • Develop and maintain a close liaison with project client contacts, core team members, and Project Managers to drive the data management aspects of project delivery.

    Job 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 (eCFR) 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 systems 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.

    Experience Required

    • 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 / 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 managerial and interpersonal skills






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