About this role

Accountable for the operational delivery of clinical study/studies to time, quality, and budget
Support decision-making and lead study team to achieve overall study deliverables
Proactively identifies, oversees, and mitigates study risks
Ensures appropriate stakeholder communication regarding study status, expectations, risks and issues
Operate within the study budget
Leads investigator meetings and other study related meetings
Oversees activities of countries participating in the study

Bachelor’s degree in life sciences or related discipline
At least 5+ years of relevant study management experience on a global level
In-depth experience in clinical research: study management, monitoring, data management
Previous in-depth Oncology experience
Experience from study feasibility to CSR
Proven experience from Ph II and PIII studies
Cross-functional leadership skills
Ability to input in clinical protocol, ICF, and other study plans
Strong experience in clinical budget management
Strong experience with vendor management including CRO
Exposed to competent authority Inspections (FDA, EMA, MHRA, PMDA...)

Global Study Manager – FSP

Key skills