Job Description

As a Laboratory Project Manager, you will oversee the full lifecycle of clinical laboratory projects, ensuring compliance with GLP/CAP/GCP regulations, on-time delivery, and budget adherence. You will lead cross-functional teams, optimize laboratory workflows, and drive client satisfaction through strategic communication and risk mitigation.

Key Responsibilities

1. Project Planning & Execution

• Lead the development of project plans, defining objectives, timelines, budgets, and resource allocation in alignment with service agreements.
• Manage end-to-end project execution, including bio-sample import/export permit applications, document development, query resolution, and status reporting.
• Ensure accurate and timely client communication (e.g., progress updates, delivery milestones), achieving ≥95% client satisfaction.

2. Team Leadership & Resource Management

• Build and lead cross-functional teams (scientists, data analysts, technicians), assigning tasks and evaluating performance (KPIs: task completion rate, document accuracy).
• Ensure team access to critical materials, systems, and training to minimize delays.
• Coordinate with external partners (e.g., subcontractors, third-party labs) to streamline supply chain efficiency.

3. Quality Assurance & Compliance

• Enforce GLP/CAP/GCP and local regulatory standards, achieving zero major non-conformances (NCs) during audits.
• Identify and resolve quality issues (e.g., data discrepancies, equipment failures), implementing CAPA (Corrective and Preventive Actions) with 100% closure rates.
• Support BD project bidding by providing technical feasibility analysis and resource assessments.

4. Cost Control & Process Optimization

• Monitor budgets (reagents, outsourcing services) and achieve annual cost savings through process improvements.
• Drive adoption of digital tools (LIMS, ERP systems) to reduce manual effort.
  

Qualifications

Education

• Bachelor’s degree or equivalent in Life Sciences, Pharmacy, Medical Technology, or related fields.
  

Experience

• 3+ years of laboratory project management experience in GLP/clinical environments.
• Proven leadership in ≥3 Phase I-III clinical trials.
• Familiarity with FDA/EMA/NMPA regulations and ICH guidelines is preferred.
  

Core Competencies

• Technical: Expertise in bioanalytical methods, sample management, and tools like GraphPad Prism.
• Software: Proficiency in Microsoft Project, LIMS, and ERP systems.
• Soft Skills: Exceptional communication, problem-solving, and risk management abilities.
  

Certifications

• PMP (Project Management Professional) or PRINCE2 certification (preferred).
• GCP (Good Clinical Practice) training certificate (preferred).
  

Preferred Qualifications

• Experience in laboratory accreditation (e.g., ISO 17025, CAP certification).
• Knowledge of international sample import/export regulations (e.g., China’s Human Genetic Resources Administration Regulations).
• Fluency in English (written and verbal), with international project collaboration experience.