CRU Operations Manager
ExternalS$120KโS$180K/yrFull-timeUnknownToday
ComplianceDocumentationGCPLeadershipStakeholder Management
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About the role
We are seeking an experienced CRU Operations Manager to oversee clinical research unit (CRU) operations, ensuring the successful execution of clinical studies while maintaining regulatory compliance, operational excellence, and high-quality project delivery. This leadership role requires close collaboration with internal stakeholders, sponsors, CROs, and cross-functional teams to drive study success. ๐ Location: Buona Vista ๐ฐ Salary: Commensurate with experience ๐ Working Hours: Monday - Friday, 8:30 AM - 5:30 PM
Responsibilities
- Lead and oversee the operational delivery of clinical studies, ensuring projects are executed efficiently and milestones are achieved.
- Provide operational leadership to cross-functional study teams and coordinate with sponsors, CROs, and internal stakeholders to resolve study execution issues.
- Review study feasibility, operational planning, project timelines, and resource allocation to support successful study implementation.
- Ensure compliance with Good Clinical Practice (GCP), IRB requirements, regulatory guidelines, and internal SOPs throughout the study lifecycle.
- Drive continuous process improvements through root cause analysis, CAPA implementation, and operational excellence initiatives.
- Oversee IRB submissions, study documentation, SOP reviews, and clinical operational records to ensure quality and regulatory compliance.
- Manage CRU equipment lifecycle, operational capabilities, and system ownership to support ongoing clinical research activities.
- Lead or support audits, inspections, self-assessments, and quality governance activities to maintain inspection readiness.
- Manage, coach, and develop a high-performing team while setting performance objectives aligned with business goals.
- Travel overseas for business purposes when required.
Requirements
- Degree in Life Sciences, Pharmacy, Nursing, Biomedical Science, or a related discipline.
- Proven experience managing clinical research operations or clinical trial execution within a Clinical Research Unit (CRU), CRO, pharmaceutical, or healthcare environment.
- Strong knowledge of GCP, IRB processes, regulatory requirements, and clinical research operations.
- Demonstrated leadership and people management experience with the ability to lead cross-functional teams.
- Excellent stakeholder management, project management, communication, and problem-solving skills.
- Willingness to travel overseas for business when required.
- ๐ฉ To apply, please click "Apply Now" or send your updated resume to dor----@recruitlync.com .
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