
Clinical Study Manager
19 hours ago
Job Overview
This role is a key contributor to the success of our clinical studies, overseeing site selection, initiation, monitoring, and close-out.
The ideal candidate will ensure high-quality data is generated on time and within set parameters, adhering to regulatory requirements.
Key Responsibilities:
- Site Management: Conduct thorough site assessments, prepare and conduct site initiation visits, and monitor study progress to achieve targets.
- Training: Deliver ongoing training to site staff on ICH-GCP, GCP, study protocol, and requirements, ensuring a thorough understanding of the study objectives.
- Documentation: Ensure timely collection and maintenance of essential documents in compliance with protocols and regulations.
- Drug Safety: Disseminate safety information to sites according to SOPs and applicable regulations, ensuring timely reporting of SAEs.
- Finance and Administration: Manage budgets, secure contracts, and execute payment schedules in accordance with company policies.
- Study Tools and System: Maintain and update study tools/systems in a timely manner.
Qualifications:
- Bachelor's degree or higher in Medical, Pharmacology, or Biology-related majors.
- At least one year of CRA experience, with a strong understanding of Good Clinical Practice and clinical trial operations processes/procedures.
- Proficiency in Microsoft Office applications, including Word, Excel, PPT, and Outlook.
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