We are seeking skilled professionals to ensure the timely and high-quality delivery of site monitoring activities in accordance with our Site Monitoring Plan (SMP).
Our team is responsible for managing sites according to the Site Monitoring Master Plan (SMMP) and relevant regulations to reduce Quality Assurance (QA) audit observations.
Key responsibilities include:
* Deliver on the Site Monitoring Plan: Understand the Site Monitoring Master Plan (SMMP), study protocol, and project plan to ensure adherence to quality standards and timelines.
* Site Management Compliance: Manage sites according to the SMMP and relevant regulations to reduce Quality Assurance (QA) audit observations.
* Site Identification: Assist in identifying new potential sites across various therapeutic areas to expand our clinical network.
* Continuous Skill Development: Regularly improve technical and soft skills to enhance performance and project outcomes.
Collaboration with the site monitoring team, site personnel, HR, site leads, and administrative staff is essential for successful project execution. Key success factors include timely and high-quality execution of site monitoring activities, prompt report generation and submission to stakeholders, and meeting education and experience requirements.
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 skills; ability to multitask and work effectively under demanding timelines.
A strong commitment to quality and adherence to timelines is crucial for efficient delivery and overall success of projects. If you possess these qualifications and share our passion for delivering exceptional results, we encourage you to apply for this opportunity.
The ideal candidate will have a proven track record of successfully executing site monitoring activities, ensuring compliance with regulatory requirements, and contributing to the growth of our clinical network.