• Lead Data Manager

    Job Location(s) US-TN-Nashville | US-PA-Philadelphia | US-NC-Raleigh-Durham | US-IL-Chicago | US-NC-Wilmington | US-NJ-Princeton | US-NC-Durham
    Job Number
    Job Category
    Clinical Data Management
    Position Type
  • Job Overview

    Lead Data Manager (all levels)

    Office based in TN or Home-Based in the US or Canada


    The selected candidate will serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities and develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.


    Additional responsibilities include:

    • Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and + Coordinate and participate i n the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to these specificationsImonitoring conventions.+ Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical suppo1t, drug safety, etc.) to suppo1t the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
    • Coordinate the development and testing of data management systems edit I data validation checks) diagnostics) and special listings I procedures used as tools for the data review and discrepancy management activities.
    • Review data acquisition conventions and data review guidelines I diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion
    • Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
    • Advanced planning and risk management for projects (issue escalation, resource management).
    • Assist with goal creation and performance review assessment for data review project staff.
    • Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.+ Support achievement of project revenue and operating margin for data management activities to agreed target
    • Identify areas for process and efficiency improvement and implement solutions on assigned projects.
    • Maintain technical data management competencies via pa1ticipation in internal and external training seminars.
    • Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget. 
    • Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as
    • Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
    • Perform other duties as assigned by management.
    • Review literature and research technologies/procedures for improving global data management practices.




    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).
    • Additional relevant work experience will be considered in lieu of formal qualifications
    • Broad knowledge of drug development
    • Understanding of global clinical development budgets and relationship to productivity
    • Knowledge of effective clinical data management
    • Knowledge oftime and cost estimate development and pricing
    • Thorough knowledge of TCH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing


    Minimum 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 I biotechnological companies 
    • Ability to lead by example teams on project strategies and achievement of depa11ment goals, objectives, and initiatives and to encourage team members to seek sol
    • Demonstrated managerial and interpersonal skills


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