- University/collegedegree (life science, pharmacy or related subject preferred), or certification
- in a related allied healthprofession from an appropriately accredited institution (e.g., nursingce11ification, medical or laboratory technology).
- Additional relevant work experience will be considered in lieu of formal qualifications.
- Broad knowledge of drug development processes.
- Understanding of global clinicaldevelopment budgets and relationship to productivity targets.
- Knowledge of effective clinicaldata management practices.
- Knowledge oftime and cost estimate development and pricing strategies.
- Thorough knowledge of TCH Guidelines and GCP including international regulatoryrequirements for the conduct of clinical development programs,especially as related to datahandling and processing.
+ Minimum five (5) years relevant workexperiencein data managementwith approximatelyone (1) yeartechnicalsupervisoryexperience toinclude data management,clinicaloperations, and knowledgeof severaltherapeuticareas.
- Demonstrated skill fortechnicalmanagement of staff exceeding 5 employees.
- Financialmanagementof gross revenuesin excess of $250K per
- Excellentoraland writtencommunication and presentation skills.
- In depthknowledge of clinicaltrialprocess and datamanagement,clinicaloperations,biometrics,qualitymanagement,andsystemsapplications to supportoperation
- Workingknowledgeof the relationship and regulatoryobligationof the CRO industry withpharmaceuticalI biotechnological
- Ability to lead by example teams on project strategies and achievement of depa11ment goals,objectives, and initiatives and to encourage team members to seek solutions.
- Demonstrated managerialand interpersonal skills
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