Remote Clinical Research Monitoring Lead

Zydus Therapeutics; Fully; Vor Ort; CHF 81.000 - 89.000; Vollzeit

Zusammenfassung

Zydus Therapeutics is seeking a remote Monitoring Specialist to oversee site monitoring activities in global trials. You will manage SQVs, SIVs, PMVs and COVs while ensuring protocol adherence, patient safety and data integrity across multiple sites.

The role requires strong knowledge of ICH GCP, GDP, ALCOA, and the ability to train site staff, review safety data, and coordinate with cross-functional teams. Extensive travel is expected to support monitoring activities.

Qualifikationen

• Must display proper knowledge of ICH GCP principles and GDP knowledge for compliance with document review/ reporting; ALCOA principles
• Must be able to demonstrate proper organizational skills and have effective communication skills
• Must be able to work independently managing sites with minimal oversight
• Must be able to demonstrate ability to conduct presentations as necessary
• Must be able to assist and have experience with oversight of sponsor monitoring activities. This will include: Data interpretation, conflict resolution and demonstration of working with different personnel, & provide guidance and solutions for complex issues
• Must have basic knowledge of system tools and web based applications that include, but not limited to: Microsoft Outlook, Excel, Word and Powerpoint
• CTMS, EDC, eTMF and IWRS systems

Aufgaben

• Responsible for all aspects of site monitoring activities; Including SQVs, Site Initiation Visits (SIVs), Periodic Monitoring Visits (PMVs) and Close-out Visits (COVs) in accordance with ICH/GCP principles.
• Act as the primary contact/ manager for sites to include, but not limited to the following activities:
• Provide proper training and guidance to site staff on the protocol and all study related materials
• Ensure appropriate safety monitoring, per ICH/GCP principles, are reviewed on an ongoing basis and ensure site has proper oversight of safety reporting requirements
• Acts as the primary contact to assigned sites to ensure there is proper compliance to the protocol, adherence to patient safety, proper IP management and study supply management
• Review sites recruitment and enrollment activities and assist with recruitment planning and solutions as needed.
• Ensure proper review of the sites Investigational Site File Binder and ensure all plans, communications and logs are maintained and updated appropriately as per ICH GCP and GDP requirements
• Will provide support to all functional groups (as needed) to ensure proper reporting of safety data and proper site compliance to all protocol and protocol related materials
• Will perform site oversight to prevent noncompliance, elevate noncompliance issues and provide guidance/ preventative action plan to prevent future noncompliance as needed

Kenntnisse

ICH GCP

GDP knowledge

ALCOA

Organisation

Communication

Independent work

Presentations

Sponsor monitoring oversight

Data interpretation

Conflict resolution

Microsoft Office

CTMS/EDC/eTMF/IWRS

Tools

CTMS

EDC

eTMF

IWRS

Jobbeschreibung

Zydus Therapeutics is seeking a remote Monitoring Specialist to oversee site monitoring activities in global trials. You will manage SQVs, SIVs, PMVs and COVs while ensuring protocol adherence, patient safety and data integrity across multiple sites.

The role requires strong knowledge of ICH GCP, GDP, ALCOA, and the ability to train site staff, review safety data, and coordinate with cross-functional teams. Extensive travel is expected to support monitoring activities.