Country Study Manager — Hybrid Clinical Operations Lead

AstraZeneca plc; Warszawa; Hybrid; PLN 180,000 - 320,000; Full time

Job summary

Alexion is seeking a Country Study Manager for Warsaw to oversee country-level delivery of clinical studies in compliance with GCP and regulatory requirements. This role collaborates with SSU, CSA, and CRAs to ensure timely study commitments and may engage with Regulatory Authorities and Ethics Committees on submissions.

The CSM ensures site activation requirements are met for the planned number of centers, working closely with the HCO/AD COM to ensure adequate study resourcing and to provide

Qualifications

• Proven experience in the oversight and delivery of operational aspects of all stages of clinical trial process.
• Experience with regulatory requirements and GCP guidelines.

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 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
• 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 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.

Skills

Fluent English

Polish

Leadership

Communication

Education

Bachelor's degree or equivalent

Tools

MS Office

Job description

Alexion is seeking a Country Study Manager for Warsaw to oversee country-level delivery of clinical studies in compliance with GCP and regulatory requirements. This role collaborates with SSU, CSA, and CRAs to ensure timely study commitments and may engage with Regulatory Authorities and Ethics Committees on submissions.

The CSM ensures site activation requirements are met for the planned number of centers, working closely with the HCO/AD COM to ensure adequate study resourcing and to provide