Covance Technical Manager Data Management in Mumbai, India

Job Overview

  • Serve as a technical expert of data management.

  • Assist in the development of global standardization of data management processes and process improvement and efficiency that will deliver accurate, timely, consistent, and quality clinical data, including the support of SOP review.

  • Identify and implement solutions to data management issues and concerns, including proactive prevention strategies based on metrics and forecasts

  • Troubleshoot projects requiring assistance from an operational or financial perspective

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

  • Interact and collaborate with other project and specialty team members (clinical, programming, statistics, drug safety, etc.) to support the development of process improvement initiatives

  • Maintain technical data management competencies via participation in internal and external training seminars.

  • Support the technical mentoring of data review staff in regional locations through specific training workshops including maintenance of those reference materials.

  • Enhance the technical ability of the data review staff through troubleshooting.

  • Review literature and research technologies / procedures for improving global data management practices, making recommendations to Senior Leadership around innovations which data management could pursue.

  • Identify areas for process and efficiency improvement and implement solutions on assigned projects.

  • Assist in defining / assessing global productivity and quality indicators for clinical data management.

  • Assist in the formulation of short-term and long-term strategies to improve project data management efficiencies. Education:

  • 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 process.

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

  • Thorough knowledge of effective clinical data management practices.

  • 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.

  • Experience:

  • Minimum six (6) years relevant work experience in data management with approximately three (3) years technical experience in data management.

  • 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 interpersonal skills.

  • Advanced Excel skills.

Education/Qualifications

  • 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 process.

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

  • Thorough knowledge of effective clinical data management practices.

  • 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.

Experience

  • Minimum six (6) years relevant work experience in data management with approximately three (3) years technical experience in data management.

  • 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 interpersonal skills.

  • Advanced Excel skills.

Job Number 2018-20748

Job Category Clinical Operations

Position Type Full-Time

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