Senior/ Clinical Research Project Operations Manager

Key Responsibilities: • Lead planning, coordination, and execution of clinical studies within the CRU. • Work with internal teams and external sponsor to ensure smooth implementation of study protocols. • Oversee multiple studies and operational activities to ensure timelines, quality, and deliverables are met. • Provide input on study design, feasibility, and operational planning. • Coordinate cross-functional teams to resolve study-related issues and ensure consistent execution. • Provide operational leadership and subject matter expertise on CRU processes, IRB requirements, and regulatory compliance. • Oversee IRB submissions, CAPAs, SOP reviews, and quality governance activities. • Support feasibility assessments, RFI/RFP reviews, and identification of capability gaps. • Ensure readiness for audits and inspections, and support continuous improvement initiatives. • Maintain operational documentation, metrics, and study tracking systems. • Ensure compliance with GCP, IRB approvals, regulatory requirements, and internal SOPs. • Track and communicate study progress, risks, and operational updates to stakeholders. • Lead post-study reviews and support implementation of lessons learned. • Promote proper documentation of decisions, actions, and meeting outcomes. • Supervise, coach, and develop team members within the CRU. • Set objectives aligned with organisational and sponsor priorities. • Support performance management and team development. • Lead cross-functional collaboration and stakeholder engagement across global teams. Career Leveling (Based on Experience & Sustainability): Candidates may be considered for either Manager or Senior Manager level, depending on experience, capability, and job scope fit. Manager Level (Typically 5+ years experience): • Focuses on coordination of multiple clinical studies and operational planning. • Involved in cross-functional and project-level decision making. • Supports execution and delivery of study activities across teams. Senior Manager Level (Typically 10+ years experience): • Oversees overall CRU operations, strategy, and portfolio-level delivery. • Responsible for department-level leadership and operational governance. • Drives long-term capability building, quality systems, and strategic decision making. Requirements: • Degree in Science, Nursing, or related health/science field. • Possess more than 5 to 10 years of experience in clinical research, preferably in clinical operations or project management . • Strong knowledge of GCP, clinical trial processes, and regulatory requirements. • Strong leadership, communication, stakeholder management, and problem-solving skills. • Experience in early-phase clinical research is preferred. • Ability to work across cross-functional and global teams. • Willingness to travel occasionally and participate in after-hours meetings when required. JOBSTUDIO PTE. LTD. EA License No: 10C4754 EA Personnel: Lim Son Qie EA Personnel Reg No: R26161791 #J-18808-Ljbffr