- Excellent opportunity for your professional development.
- Opportunity to integrate a solid project with the possibility of growth.
Sobre o nosso cliente
- Responsible to deliver committed components of clinical studies according to agreed resources,budget and time lines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations;
- Perform site monitoring as needed to support the flexible capacity model;
- Responsible to ensure that sites are identified, site qualifications performed, set up, initiated,monitored, closed and documentation archived;
- Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment and conducting Site Qualification Visits to evaluate suitability and quality risks;
- Sets up and maintains the study in CTMS and other applicable platforms at study country level as required by local laws and regulations, as well as all applicable study Plans and documents;
- Oversees and coordinates monitoring activities from site activation through study closure at country and site level in accordance with the Monitoring Plans;
- Reports study progress/update to the Evidence Generation Manager on a weekly basis,concerning study/ies KPIs,milestones and key issues;
- Assists in forecasting study time lines, resources, recruitment, study materials and drug supplies;
- Works together with the Evidence Generation Manager and with the Regulatory Affairs Team to ensure timely delivery of publications
- Degree in Life Sciences;
- Experience of Study Management within a pharmaceutical or clinical background;
- Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management;
- High capacity for interpersonal relationships;
- Excellent communication skills, organized and autonomous;
- Good leadership skills;
- Fluent in English-Written and spoken.
Excellent opportunity for your professional development.