Regulatory and Start Up Specialist
iqvia · Belgrade
Description du poste
About the role
This position supports site activation activities at a country level, ensuring compliance with local and international regulations, SOPs, and project requirements. The role is home‑based and serves as the single point of contact for investigative sites and internal teams.
Key responsibilities
- Act as the Single Point of Contact for assigned studies, coordinating with sites, Site Activation Managers, and project teams.
- Perform start‑up and site activation tasks, distribute documents, and maintain internal tracking systems.
- Prepare and review regulatory documents for completeness and accuracy, and monitor approval timelines.
- Provide local regulatory expertise during project planning and execute contingency plans as needed.
Required profile
- Experience with regulatory and contract documentation in clinical research.
- Ability to work independently in a remote setting and communicate effectively with multiple stakeholders.
Required skills
- Knowledge of site activation processes and regulatory requirements.
- Proficiency in maintaining databases and tracking tools.
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iqvia
Belgrade