[Alexion] Country Study Manager

Responsibilities

• ● Quality and timeliness of study deliverables (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation) for assigned study(ies).
• ● Proactive reporting of study-specific issues (including monitoring metrics) to the global study team and country leadership team
• ● Quality of monitoring oversight in the assigned study(ies)
• ● Meeting recruitment targets for assigned study(ies).
• ● CDA delivery and negotiation (based on pre-approved parameters and regardless of executory party).
• ● ICF customization at country/site level for the assigned studies.
• ● Negotiation of site study contracts and budgets for the assigned studies at country level.
• ● Review of local regulatory documentation and oversight of local regulatory activities.
• ● Relationship management with the national coordinating investigator as applicable and coordination of country level engagement activities.
• ● Leading recruitment discussions at local level for the assigned trials.
• ● Timely and accurate responses to queries from the study team.
• ● Conduct of site feasibility for allocated studies
• ● Conduct and/or oversight of EC/CA submissions and facilitate resolution of queries.
• ● Coordination of study specific training of CRAs for assigned trials.
• ● Oversight of dedicated or FSP CRAs on assigned studies, when applicable.
• ● Reviewing Clinical Monitoring Documentation (reports, metrics, etc) for the assigned studies.
• ● Inspection readiness activities coordination at local level for assigned studies.
• ● Driving quality efforts to proactively identify and manage risks to study quality.
• ● Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).
• ● Driving performance at the sites. Proactively identifying and ensuring timely resolution to study-related issues and escalates them as appropriate.