Clinical Data Manager
Covance
Milan, Italy
1 gg fa

Job Overview :

Lead Data Manager (Clinical Data Manager)

Home-Based or Office-Based.

Get ahead in your career and make a difference in people’s lives

Are you a self-starter who knows how to take initiative in your daily work? Would you enjoy making a real difference in the lives of others.

If you are looking for a high-energy position in a collaborative environment, learn more about the Lead Data Manager opportunity with Covance.

In this role, you will :

  • 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.
  • Education / Qualifications :

  • 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.
  • 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.
  • Experience :

  • 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.
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