Quality and Compliance Assessor

Overview

Quality and Compliance Assessor – Syneos Health, Kuala Lumpur, Malaysia.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Why Syneos Health : we are committed to developing our people, with career development and progression, supportive line management, training, peer recognition and a total rewards program; we embrace a Total Self culture; and we believe diversity of thoughts and backgrounds strengthens our teams. We operate globally with a culture of belonging.

Responsibilities

• Performs Routine and Non-Routine Monitoring Evaluation Visits (MEVs) and / or Sign Off Visits (SOVs) as assigned.
• Assists in the analysis of qualitative oversight data to identify quality improvement signals.
• Conducts root cause analysis of quality signals and develops a plan and / or recommended actions, including supporting implementation of process and efficiency improvements.
• Identifies training needs for CRAs through analysis of aggregated oversight data to meet standards in quality and efficiency across Global Clinical Operation (GCO).
• May conduct trainings on areas of improvement identified through quality oversight data analysis and / or audit findings in collaboration with Learning Center of Excellence, Corporate Quality and Clinical Operations Management.
• Supports Clinical Operations in addressing ad hoc or escalated quality concerns within the region.
• Acts as consultant to local / regional operations related to quality oversight best practices and tools.
• May assist in the review of Clinical Monitoring SOPs, tools or templates related to monitoring oversight.
• Performs other work-related duties as assigned.

Qualifications

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health at .

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