Clinical Research Site Manager
Há 3 dias
As a Site Manager, you will play a vital role in ensuring the success of our clinical trials by overseeing site monitoring and management activities. Your primary responsibility will be to conduct regular site visits to verify compliance with contractual scope and regulatory requirements.
Key Responsibilities Include:
- Conducting site selection, initiation, monitoring, and close-out visits according to contracted scope and regulatory requirements.
- Collaborating with sites to adapt, drive, and track subject recruitment plans in line with project needs.
- Providing protocol and study training to assigned sites and maintaining regular communication to manage ongoing project expectations and issues.
- Evaluating the quality and integrity of study site practices related to the protocol and adherence to regulations, escalating any quality issues as necessary.
- Managing study progress by tracking submissions, approvals, recruitment, case report form completion, and data query generation and resolution.
- Maintaining documentation regarding site management, monitoring visit findings, and action plans by submitting regular reports and generating follow-up letters.
- Bachelor's Degree in a scientific discipline or healthcare preferred.
- Excellent English command (written/spoken).
- Knowledge of clinical research regulatory requirements (GCP and ICH guidelines).
- Therapeutic and protocol knowledge provided through company training.
- Attention to detail and excellent communication skills.
- Problem-solving, judgment, and decision-making abilities.
- Proficiency in Microsoft Word, Excel, and PowerPoint, as well as laptop and mobile device use.
- Verbal and written communication skills, including good English language command.
- Organizational and problem-solving skills.
- Time and financial management skills.
- Able to establish and maintain effective working relationships.
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