Sponsor Oversight Monitor - Malaysia

About the Company

AnRes Clinical is a Clinical Development Consultancy specialising in Sponsor Oversight including Clinical Monitoring Oversight on behalf of the Sponsor. Therapeutically, we are focusing on Oncology, Neurology as well as Autoimmune and Rare diseases. We assist biotech companies in gathering high-quality clinical evidence which will support Marketing Authorisations. AnRes Clinical offers expertise with a partnering mindset to support informed decision making and risk assessment for biotech companies.

What is the Role of Sponsor Oversight Monitor about

This is a long-term freelance remote role as a Sponsor Oversight Monitor (SOM) at AnRes Clinical. The SOM will be responsible for overseeing and ensuring the quality and compliance of clinical trials conducted by global CROs for biotech companies.

This role involves:

· Performing Monitoring Oversight Visits (MOV) at selected sites approximately every 6-12 months

· Identifying and communicating risks, issues and proposing workable solutions to the identified issues

· Diplomatic and comprehensive communication with the CRO, AnRes Clinical Oversight PM and the Sponsor providing a complete picture of patient safety and data integrity in a specific clinical trial at selected sites

· Reporting as per Monitoring Oversight SOP

Your qualifications:

• Extensive experience as a Clinical Research Associate (10 years+) or as a GCP Auditor
• Previous clinical trial leadership experience
• Experience in preparing, coordinating or attending regulatory inspections
• Oncology experience is a must
• Diplomacy and effectiveness with high recruiting sites
• QA focused mindset
• Excellent knowledge of GCP (R3) and the local regulations

Duration of the contract: 1-2 years

For transparency this is a low FTE assignment, but we hope a very rewarding one since you will become part of a global SOM team.

For any questions, please contact: [Confidential Information]

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We are looking forward to hearing from you!