Data management leadership on a large I global project, 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.
+ University/college degree (life science, pharmacy or related
subject preferred), or certification in a related allied health p
profession from an appropriately accredited institution (e.g., n
nursing certification, medical or laboratory technology).
+ Additiona l relevant work experience will be considered in lieu
of formal qualifications
+ Broad knowledge of drug development process.
+ Thorough knowledge of effective clinical data management
+ Thorough knowledge of ICH Guidelines and GCP including
international regulatory requirements for the conduct of clinical
development programs , especially as related to data handling
+ Thorough knowledge of time and cost estimate development
and pricing strategies.
+ Understanding of global clinical development budgets and
relationship to productivity targets.
+ Minimum seven (7) years relevant work experience in data
management with four (4) years 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 communicat ion and presentation
+ 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
+ Demonstrated skill for mentoring and developing staff on
technical and core competencies.
+ Working knowledge of the relationship and regulatory
obligation of the CRO industry wit pharmaceutical I
+ 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 2018-20750