Covance Clin Data Mgr I in Durham, North Carolina

Job Overview

Clinical Data Manager

Home-Based in the US or Canada

The selected candiate will be responsible for 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. Also will 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.

Essential 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.


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 processes.

  • Understanding of global clinical development budgets and relationship to productivity targets.

  • Knowledge of effective clinical data management practices.

  • 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.


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 / 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

Job Number 2019-29357

Job Category Clinical Data Management

Position Type Full-Time

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