Job Overview:
">
This role involves delivering site monitoring activities in alignment with the Site Monitoring Plan (SMP). The primary goal is to ensure timely and qualitative delivery of these activities.
">
Key Responsibilities:
">
* Deliver on the Site Monitoring Plan: Gain a comprehensive understanding of the Site Monitoring Master Plan (SMMP), study protocol, and project plan to ensure adherence to quality and timelines.
* Site Management Compliance: Manage sites according to the SMMP and relevant regulations to minimize Quality Assurance (QA) audit observations.
* Site Identification: Assist in identifying new potential sites within various therapeutic areas to expand our clinical network.
* Continuous Skill Development: Regularly enhance both technical and soft skills, applying them to elevate performance and project outcomes.
Work Relations:
">
* Report to the Manager of Clinical Operations for project, functional, and administrative matters.
* Collaborate with the site monitoring team, site personnel, HR, site leads, and administrative executives.
Value Added:
">
Your adherence to the quality and timelines of the monitoring plan will be crucial for the efficient delivery of our projects and overall success.
">
Key Success Factors:
">
* Timely and high-quality execution of site monitoring activities.
* Prompt report generation and submission to stakeholders.
Essential Skills Experience:
">
* Education: Bachelor's or Master's degree in a scientific discipline.
* Experience: 1-4 years of experience in site monitoring within clinical research.
* Skills: Strong understanding of ICH GCP and applicable clinical trial regulations; excellent verbal and written communication; ability to multitask and thrive under demanding timelines.