SSO Associate Clinical Project Manager
On-siteOsaka, Osaka, Japan or Fukuoka, Fukuoka, Japan
Job Summary
Lead planning, execution, and interpretation of clinical trials research, data collection activities, and clinical operations. Monitor patient data and study-related information from source documents, research records, and site visits to ensure investigators adhere to protocols, regulatory requirements, and good clinical practices. Oversee operational activities including budgeting, initiation visits, site closeouts, and training of study personnel on protocols and drug handling. Prepare and collect site documents, review Monitoring Visit Reports, and report technical complaints or adverse events within 24 hours. Collaborate with global clinical teams, vendors, and consultants to deliver studies to quality standards and agreed timelines while managing costs.
Required Qualifications
- Expert on monitoring processes, procedures, and systems
- Full understanding of area of specialization
- Ability to resolve a wide range of issues in creative ways
- Networks with senior internal and external personnel in own area of expertise
- Contributes to many cost center goals and objectives
- May contribute to service line goals
- Ability to review and sign off Monitoring Visit Reports
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
- Distribution of marketing samples (where applicable)
- Delivery of Clinical Trials to quality standards, agreed timelines, number of patients, costs and quality
- Adherence to Novartis policy and guidelines and external regulations
- Clinical Research
- Clinical Study Reports
- Clinical Trials
- Collaboration
- Data Analysis
- Financial Analysis
- Health Sciences
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