Primary contact for FSP and other monitoring services (vendors) to assure adequate quality of the services & performance in the clients sponsored clinical trials. Oversees vendor monitoring performance targets per defined quality performance indicators, including site recruitment commitments, timely data entry and issue resolution KPIs. Aligns with FSP and other vendor's managers on CRA and other vendor resource related allocation to trials and studies. Requires strong communication skills and ability to influence internal and external stakeholders in order to maximize quality and efficiency of external service providers.
Ideal Background
- A degree in scientific or health discipline required and advanced degree preferable (or, for United States: 4-year degree plus relevant, related healthcare experience)
- Fluent in both written and spoken English
- Minimum 7 years' experience in clinical research - planning/executing and/or monitoring clinical trials
- Experience and evidence of team leadership capabilities
- Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
- Decision making capability
- Excellent management capabilities with demonstrated capability to problem solve and mediate complex compliance issues.
- Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and the clients standards
- Demonstrated negotiation and conflict resolution skills
- Fast change adaptability to best partner & influencing with FSP vendor on fast changing landscape
- Trust and rapport building is a very important skill needed
- Good communication skills, ability to influence others & Relationship management
- Excellent communicator and presenter (oral and written)
- Good analytical thinking
- Ability to anticipate potential issues and take appropriate actions with or without supervision
- Digital & tech capabilities
- Management
- Monitoring Data Quality
- Reporting
