Manager - Cru Operations

Manager - CRU Operations Office Location : Buona Vista, Singapore Working Hours : Monday - Friday 8.30am - 5.30pm Monthly Salary : Basic up to $14000 + Completion Bonus Employment Type : Full time, Contract Company Overview The company is a specialized clinical research unit based in Singapore, focusing on early‑phase human trials and innovative health technologies. It integrates biomedical expertise with modern digital tools to advance drug development and support global healthcare progress. Responsibility Study Portfolio Alignment – Work closely with management to align and oversee the CRU’s study portfolio. Cross‑Functional Integration – Drive coordination across CRU teams to deliver study requirements effectively. Operational Leadership – Provide leadership in study execution, participating in protocol reviews, execution meetings, and liaising with sponsors/CROs to resolve issues. Subject Matter Expertise – Act as a resource on CRU processes, IRB, and regulatory requirements; provide input on study design and feasibility. Project Oversight – Lead implementation of high‑priority clinical studies and oversee non‑clinical projects impacting CRU operations. Documentation & Improvement – Ensure proper documentation of decisions and share process improvements; conduct root cause analysis and implement CAPAs. Regulatory Compliance – Ensure adherence to protocols, IRB/regulatory requirements, GCP, global policies, and SOPs. Audit & Inspection Support – Perform self‑assessments and actively participate in audits and regulatory inspections. Equipment & Systems Oversight – Manage equipment lifecycle, act as system owner where appropriate, and oversee IRB submissions and SOP reviews. People Management – Attract, coach, and manage team members; define objectives aligned with organizational priorities and drive performance outcomes. Requirement Minimum Degree in science or health-related field. Minimum 8 years of experience in clinical research with project management and/…