Jobdescription
Project related responsibilities as of study development:
Communicates adequately with the various stakeholders and third parties on operational and logistical activities, informs the Project Manager on the expected impact in close collaboration with other members of the Clinical Operations teams.
Coordinates and oversees the operational aspects from project start up on until project closure at any time such as but not limited to:
- The collection and filing of country- and site-specific documents required for regulatory submissions (e.g. insurance, translations), site activation (e.g. access and delegation logs, protocol signature page), management and closure
- The development of study-specific guidelines and training for sites (e.g. pharmacy manual, lab manual)
- Drug supply management
- Human Biological Material (HBM) management
- The set-up collaborations with intergroups
- The maintenance of Trial Master File, Clinical Trial Management System and other tracking tools applicable to the study
- The participation to project related meetings
- The redaction of the study newsletters
- Reports to senior Clinical Operations Manager on study status and possible scope changes during regular portfolio meetings.
Contributing to the improvement of functioning of the department’s processes by:
Participating actively to expert task forces.
Identifying potential processes for improvement:
- Ensures that standard or customized reports are designed, developed, validated, maintained and documented to support the department ;
- Supports in the configuration and testing of clinical trial management tool(s) ;
- Analyzes clinical operations objectives and Key Performance Indicators (KPIs) thereby providing solutions to meet requirements.