项目经理/主管PM/SPM

About the role

The Project Manager / Supervisor (PM/SPM) is responsible for overseeing the full lifecycle of clinical trial projects, ensuring they meet quality standards, timelines, and budget constraints. This role leads cross‑functional teams, manages internal and external communications, and drives efficiency throughout project execution.

Key responsibilities

• Plan, execute, and monitor project timelines, budgets, scope, and quality for assigned clinical studies.
• Lead and coach project staff, assigning tasks, evaluating performance, and supporting professional development.
• Coordinate regulatory submissions, including IRB and local authority applications, and obtain necessary approvals.
• Manage import permits for investigational drug products and biological samples.
• Oversee preparation, tracking, and filing of trial documentation in compliance with ICH, local regulations, and SOPs.
• Facilitate issue resolution, risk management, and contingency planning across the project team.
• Communicate project progress and deliverables to customers and stakeholders.
• Contribute to the development of protocols, informed consent forms, case report forms, and other study documents.
• Evaluate and recommend qualified study sites and manage investigational product logistics.

Required profile

• Proven experience managing staff according to organizational policies, including performance coaching and mentorship.
• Strong ability to ensure team members have necessary resources, training, and system access.
• Excellent communication skills for internal and external stakeholder engagement.
• Demonstrated capability to lead problem‑solving initiatives and implement corrective actions.

Required skills

• In‑depth knowledge of ICH guidelines, IRB processes, and local regulatory requirements for clinical trials.
• Expertise in project planning, budgeting, and timeline management.
• Experience with investigational product handling, import permits, and trial material logistics.
• Proficiency in preparing and reviewing SOPs, study management plans, and database maintenance.