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Job Title 10: Clinical Data Manager (3个)
Job Summary:
Data management leadership on a large/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.
Job Qualification:
Minimum 5 years relevant work experience in data management with approximately 1 year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
Demonstrated skill for technical management of staff exceeding 5 employees.
financial management of gross revenues in excess of $250K per year
Excellent oral and written communication and data management,clinical,operations,biometrics,quality management, and sustems applications to support operations
Working knowledge of the relationgship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.
Ability to lead by example teams on project strategies and achievement of department goals,objectivities,and initiatives and to encourage team members to seek solutions
Demonstrated managerial and interpersonal skills.
University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or
certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer
science, 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 clinicaldevelopment budgets and relationship to productivity targets
Knowledge of effective clinical data managerment practices
Knowledge of time and cost estimate development and pricing strategies
Thorough knowledge ofICH Guidelinesand GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing
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