quality from Study Specifications through study closeout activities and Clinical Study Report.
To lead Local Study Team at country level to deliver committed components of clinical studies
according to agreed resources, budget and timelines complying with DZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. Provide co-monitoring to CRAs to ensure study quality reaching/above global level. Develop and maintain excellent working relationships with external and internal customers to ensure the smoothly and timely delivery of clinical studies.
In addition to leading LST(s), LSTL is expected to perform site monitoring if needed. As part of the flexible capacity model it is expected that LSTL manages both roles.
LSTL is responsible to ensure that sites are identified, site qualifications performed,
set up, initiated, monitored, closed and documentation archived.
Overall responsibility for the study commitments within the country, for timely delivery of data to required quality.
Contribute and support global study lead on overall study deliveries.
Lead Local Study Team(s) consisting of monitors and study administrator(s).
Lead and optimise the performance of the local Study Team(s) at country level ensuring compliance with DZ Procedural Documents, ICH-GCP and local regulations
and to update other study team members on study matters
Lead development of Local Monitoring Plan as per Targeted Monitoring guidance from
respective Study Team.
Contribute to review of monitoring visit reports and pro-actively advice the Monitor(s) on
study related matters.
Proactively identify and facilitate resolution of complex study problems and issues.
Organise regular Local Study Team meetings on an agenda driven basis.
Actively work towards achieving good personal relationships with all local Study Team
Report study progress/update to the SMO Study Leader/Team.
Investigators as necessary.
Lead Investigator on recruitment and other study matters.
competence, etc, of the Hospitals/sites.
through external providers.
Minimum University degree and / or equivalent, preferred in biological science or healthcare-related field.