Google Cloud PlatformGCPGoogle CloudProject ManagementStakeholder ManagementRisk ManagementCommunicationTime Management
About this role
Role Overview
Provide strategic oversight and management of clinical trial sites within CDC and Ad Hoc affiliate
Drive study quality and performance through risk-based monitoring and proactive risk management
Collaborate effectively with site staff and cross-functional teams to ensure successful execution of the trial
Conduct on-site and remote monitoring visits in accordance with the Monitoring Plan, Protocol, ICH-GCP, internal SOPs, and applicable regulatory requirements
Drive the implementation of RBQM principles to ensure high-quality execution of clinical trial activities
Actively engage with site staff and collaborate with cross-functional teams to support strong site relationships and ensure efficient clinical trial execution
Requirements
Bachelor's degree in Life Sciences or related field minimum
2+ years’ experience clinical trial monitoring or relevant pharmaceutical industry/CRO role
Strong understanding and knowledge of ICH-GCP guidelines, regulatory requirements and clinical trials methodology
Demonstrated ability to ensure high-quality execution of clinical trial activities in compliance with ICH-GCP, regulatory requirements and internal SOPs
Demonstrated ability to build and maintain strong relationships with internal and external stakeholders across all organisational levels
Excellent written and verbal communication and stakeholder management skills
Confident working in dynamic environments independently and as part of a team
Strong organisational and time management skills, with the ability to manage multiple sites and priorities
Project management capabilities with high attention to detail, integrity, and commitment to quality and patient safety
Proficiency in digital tools, including electronic data capture (EDC) systems, CTMS, eTMF, and other clinical trial software
Problem-solving and decision-making capabilities, including proactive risk identification and mitigation
Attention to detail and commitment to high-quality, compliant trial conduct
Open to embracing better ways of working and identify opportunities for continuous improvement, including new technologies and digital tools
Flexibility to travel as required.
Tech Stack
Google Cloud Platform
Benefits
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.