Global Study Manager – FSP

This is a fully remote position, open to applicants in Serbia.

📋 Description

• Responsible for the timely, quality-driven, and budget-conscious operational execution of clinical study or studies.

• Facilitate decision-making processes and guide the study team in meeting overall study objectives.

• Proactively identifies, monitors, and addresses potential study risks.

• Ensure effective communication with stakeholders regarding the status of the study, expectations, risks, and issues.

• Manage operations within the allocated study budget.

• Direct investigator meetings and other related discussions pertinent to the study.

• Supervise the activities of countries involved in the study.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field.

• A minimum of 5+ years of relevant global study management experience.

• Extensive background in clinical research, including study management, monitoring, and data management.

• Prior comprehensive experience in Oncology.

• Experience spanning from study feasibility to Clinical Study Report (CSR).

• Demonstrated experience in Phase II and Phase III studies.

• Strong cross-functional leadership abilities.

• Capability to contribute to clinical protocols, informed consent forms (ICF), and other study documentation.

• Significant experience in managing clinical budgets.

• Strong expertise in vendor management, including working with Contract Research Organizations (CROs).

• Familiarity with inspections by competent authorities (FDA, EMA, MHRA, PMDA, etc.).

🏝️ Benefits

• Health insurance.

• Reasonable accommodations for individuals with disabilities.

• Opportunities for professional development.