Covance Lead Project Data Manager in Chicago, Illinois

Job Overview

Lead Project Data Manager

permanent, salaried

Remote from anywhere in the U.S. or Canada

Job Summary

  • Data management leadership on global, large and/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.

  • Management of clinical data vendors to achieve the productivity, quality, and timeline requirements of projects.

JobDuties

  • 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 system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.

  • Advanced planning and risk management for projects (issue escalation, resource management).

  • Support recruitment of new data management candidates.

  • 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.

  • Supervise, mentor and evaluate performance of data managers in the location and aide in staff development, career development, interpersonal skills, and achievement of competency standards.

  • Support the technical mentoring of data review staff in regional locations and aide in staff development, career development, interpersonal skills, and achievement of competency standards.

  • Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.

  • 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.

ExperienceRequired

  • Minimum six (6) years relevant work experience in data management with approximately three (3) years technical supervisory experience to include data management, clinical operations, knowledge of several therapeutic areas.

  • Demonstrated skill for technical management of staff exceeding 10 employees.

  • Financial management of gross revenues in excess of $500K 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.

  • Demonstrated 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.

Education/Qualifications

Pending

Experience

Pending

Job Number 2019-26912

Job Category Clinical Data Management

Position Type Full-Time

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