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Covance Data Project Manager in Tokyo, Japan

Job Overview

Summary:

  • Data management leadership on local/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.

Duties:

  • Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.

  • Develop Data Management Plans and Quality Management 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 staffs 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

  • 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).

  • Knowledge of effective clinical data management practices

  • 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

  • Business level English/Japanese, both written and verbal

  • Ability to mentor junior members of the department, providing SME guidance on Data Management practices

  • Ability to work in a team environment and collaborate with peers

  • Good organizational ability, communication, managerial, and interpersonal skills

  • Time management skill and ability to adhere to project productivity metrics and timelines

  • Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives and to encourage team members to seek solutions

  • Constructive problem solving attitude while deadline focused with time demands, incomplete information or unexpected events

Experience

Must

  • Minimum 8 years relevant work experience in data management with approximately 3 years technical supervisory experience to include data management, clinical operations, knowledge of several therapeutic areas

  • Minimum 4 or more years of Electronic Data Capture experience

  • Minimum 2 years of experience of project or people management of technical staff exceeding 3-5 employees

Preferred

  • Experience of representing Data Management in bid defence meetings, providing innovative solutions to meet client needs.

  • Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets

  • Oncology therapeutic experience.

Job Number 2018-25571

Job Category Clinical Data Management

Position Type Full-Time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

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