Covance Senior Manager, Clinical Data Management in Horsham, United Kingdom

Job Overview

Senior Manager, Clinical Data Management

Office Based or Home-Based anywhere in the UK or Netherlands

Covance is seeking a Senior Manager with functional leadership to be responsible for delivering data management services to clients and project teams; managing clinical data vendors to achieve the productivity, quality, and timeline requirements of projects; and maintaining optimal department processes and implementing excellent project-specific strategies.

Additionally, the selected candidate will be responsible for the following:

  • Technical data management leadership or oversight on global, large and/or multiple projects with responsibility for the development of project Data Management Plan(s); data management systems set-up; and data accession, data entry and data review specifications and processes; and technical oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project(s) timelines and budgets.

  • Developing and maintaining a close liaison with project client contacts, core team members, and Project Managers to drive the data management aspects of project delivery.

  • Assisting with the development and implementation of department strategies to increase productivity and quality, while decreasing cycle times and costs to increase financial margins

Education / Qualifications

Minimum R e quir e d:

  • 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, med ical or laboratory technology).

  • Broad knowledge of drug development process.

  • 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.

  • Thorough knowledge of time and cost estimate development and pricing strategies.

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

Experience

Minimum Required:

  • Previous experience of working within clinical data management within a pharma or CRO.

  • Previous technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.

  • Demonstrated skill for technical and supervisory leadership of 8-15 staff within one or more locations in a region.

  • 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.

  • In depth knowledge of tracking of staff productivity and quality metrics.

  • Demonstrated skill for mentoring and developing staff on technical and core competencies.

  • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical and biotechnological companies.

  • Operational experience in other disciplines such as clinical, biometrics, medical writing, pharmacovigilance, safety, quality assurance, regulatory, etc.

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

  • Strong leadership and interpersonal skills.

Job Number 2018-26571

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.