Covance Senior Manager, Clinical Data Management in Leeds, United Kingdom
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.
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.