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.

Requirements:

• Degree in Science, Nursing, or related health/science field.
• Possess more than 5 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.

Interested applicants, kindly furnish us with your detailed resume in MS Words format and click "Apply Now" button

We regret to inform only shortlisted candidates will be notified. Applicants who do not possess necessary experience or qualification will still be considered on individual merits and may be contacted for other opportunities

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