项目经理/主管PM/SPM

About the role

The Project Manager / Supervisor (PM/SPM) is responsible for leading clinical trial projects from initiation to close‑out. Reporting to the PM Director, the role ensures projects meet quality standards, timelines, and budgets while coordinating internal and external stakeholders.

Key responsibilities

• Plan, execute, and monitor project timelines, budgets, scope, and quality for assigned clinical studies.
• Lead and coach project team members, assign tasks, manage performance, and support professional development.
• Prepare and submit IRB and local regulatory authority packages, obtain approvals, and manage import permits for investigational drugs and biosamples.
• Oversee trial document preparation, tracking, filing, and compliance with ICH guidelines, SOPs, and local regulations.
• Coordinate site selection, investigational product distribution, and clinical trial material logistics.
• Facilitate issue resolution, risk management, and corrective action plans, escalating as needed.
• Contribute to protocol, informed consent form, case report form, and other study documentation.
• Act as Clinical Research Associate (CRA) for site initiation, monitoring, and close‑out activities.

Required profile

• Proven experience managing staff and project teams in a regulated environment.
• Strong knowledge of IRB processes, ICH guidelines, and local regulatory requirements for clinical trials.
• Excellent communication skills for internal and external stakeholder engagement.
• Ability to mentor, coach, and develop team members.

Required skills

• ICH guideline compliance
• IRB submission and approval processes
• Clinical trial documentation management
• Regulatory import permit handling

What we offer

• Opportunity to lead high‑impact clinical research projects.
• Collaborative environment with cross‑functional teams.
• Professional development and mentorship.