- University/college degree (life science, pharmacy or related subject preferred), or certificationin a relatedallied health profession from an appropriatelyaccredited institution (e.g., nursingce1tification,medical or laboratory technology).
- Additional relevant work experience wi ll be considered in lieu of formal
- Broad knowledge of drug development proces
- Understanding of global cl inical development budgets and relationship to productivity targets.
- Knowledge of effective clinical data management
- Knowledge oftime and cost estimate development and pricing strategies.
- Thorough knowledge of ICH Guideli nes and GCP including international regulatoryrequirements for the conduct of clinicaldevelopment program s, especiallyas related to datahandling and processi
- 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 depth knowledge of clinical trial process and data management, clinical operations,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 department goals,objectives, andinitiativesand to encourageteam membersto seek solutions.Demonstrated managerial and interpersonal skills
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