• Snr Mgr EDC Validation

    Job Location(s) IN-Bangalore
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  • Job Overview

    • Functional leadership with global responsibility for delivering User Account Management/Data Entry services (data entry, user account administration, overseeing database testers and other data management related administrative tasks).
    • Assist with and implement global strategies regarding EDC database user account management and security/permission models to increase productivity and quality, while decreasing cycle times and costs to increase financial margins.
    • Manage optimal departmental processes and implementing excellent project-specific strategies
    • Develop and maintain a close liaison with project team members, and data managers to drive the technical aspects of project delivery.
    • Management of User Account Management/Data Entry vendors to achieve the productivity, quality, and timelines requirements of projects.
    • Responsible for implementing departmental strategies to ensure user accounts deployed to meet internal and external client expectations.
    • Globally manage the staff who perform the User Account Management/Data Entry aspects of projects
    • Globally manage resources to meet or exceed business Service Level Agreements
      • Globally manage the administration of EDC user account activations, deactivations and modifications
      • Globally oversee the conducting of EDC testing using test scripts provided
      • Globally oversee the copying of data to archive media following instruction provided. e.g. CD or DVD
      • Participate in the identification and implementation of solutions to local and regional data management issues and concerns, including proactive prevention strategies based on metrics and forecasts
      • Globally manage, mentor, evaluate and aid in staff development, career development, interpersonal skills, and achievement of competency standards
      • Maintain productivity and quality indicators for global staff
    • Coordinate quality management activities according to the Global Data Management Plans and Quality Management (QM) Plans and in process quality control activities to ensure staff deliver accurate, timely, consistent, and quality clinical data
      • Support global project staff on achieving client satisfaction (internal and external) through delivery of quality data, on-time and on-budget
      • Develop and execute training programs and ensure staff achievement of position competencies
    • Proactively manage departmental resourcing needs and ensure correct staffing levels or mitigation strategies
      • Support global standardization of processes, process improvements and efficiencies
      • Support development of global, harmonized SOPs and specific quality processes and procedures for User Account Management/Data Entry activities
      • Assist in the review and development of SOPs.
    • Serve as a liaison to Covance business associates (vendors) who provide services related to User Account Management/Data Entry
      • Identify and implement process improvement solutions
      • Create action plans to address staff quality and performance issues identified by clients, via client satisfaction surveys, and/or from core project team feedback
      • Manage utilization and billability of staff, planning for resource allocation / recruitment based on individual skills, competencies, and availability
      • Ensure revenue and operating margin performance of the group to agreed targets
      • Provide support to business development for time and cost estimates
      • Review literature and research technologies/procedures for improving global practices and efficiencies
      • Ensure that staff reviews (performance appraisal, training and development etc) are completed for each member in accordance with Covance guidelines
      • Perform other duties as assigned by management.


    • 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 (e.g. pharmaceutical, laboratory, data analysis) incorporating approximately one year’s clinical data management experience in addition to the five (5) year relevant work experience in User Account Management and data entry will be considered
    • Broad knowledge of drug development process
    • Understanding of global clinical development budgets and relationship to productivity targets
    • Thorough knowledge of User Account Management and data entry practices
    • Knowledge of resource management systems / processes
    • Knowledge of time and cost estimate development and pricing strategies
    • Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing




    • 11.5 to 15 years of relevant work experience with approximately three (3) years management experience to include User Account Management and data entry /management and knowledge of several therapeutic areas
    • Demonstrated skill for management of staff of 4 to 10 employees globally
    • Excellent oral and written communication and strong presentation skills
    • In depth knowledge of clinical trial process and tracking of staff productivity metrics
    • Demonstrated skill for mentoring and developing staff on technical and core competencies
    • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies
    • Demonstrated ability to lead local teams on business strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions
    • Proven managerial and interpersonal skills




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