GLP Lab Project Manager（Assoc）

该职位来源于猎聘 Major Responsibilities: Project Planning & Execution:

• Assist LPMs in developing project plans, tracking timelines, and updating resource allocation in alignment with service agreements.
• Coordinate logistics for bio-sample import/export (e.g., permit application paperwork, courier scheduling) and maintain chain-of-custody records.
• Draft and distribute project status reports, meeting minutes, and client communications (under LPM supervision).
• Monitor task progress against milestones; flag delays or bottlenecks to LPMs for resolution. -- Perform any other duties and ad-hoc tasks as assigned by the Line Manager to support the overall success of laboratory projects and departmental objectives. Team Leadership & Resource Management:
• Support cross-functional teams (scientists, data analysts, technicians) by scheduling meetings, distributing tasks, and tracking action items.
• Liaise with external partners (subcontractors, third-party labs) to confirm deliverable timelines and resolve operational gaps.
• Maintain team access to critical resources (e.g., training materials, system permissions) and escalate resource shortages to LPMs. Quality Assurance & Compliance:
• Organize and archive project documentation (e.g., protocols, SOPs, regulatory submissions) in compliance with GLP/CAP/GCP standards.
• Assist in tracking quality issues (e.g., data discrepancies, equipment alerts) and support CAPA implementation under LPM guidance.
• Prepare audit-ready documentation (e.g., training records, deviation reports) for internal/external inspections. Compliance and Risk Management:
• Update project trackers (budgets, timelines, KPIs) and generate ad-hoc reports for LPM review.
• Stay informed of basic regulatory updates (e.g., ICH guidelines, local laws) and share relevant changes with the team.
• Support business development (BD) activities by compiling historical project data for feasibility assessments (as directed by LPM). Education  Bachelor’s degree or equivalent in Life Sciences, Pharmacy, Medical Technology, or related fields. Knowledge, Skills, and Abilities  Continual education follow regular requirement.  Familiar with all lab operation activities.  Excellent working knowledge of CAP/GCP/GLP, applicable law (local and country) and regulatory requirements.  Strong motivational and team-building skills.  Ability to work independently and as part of a team in a fast-paced environment.  Effective time management and prioritization skills .  Good communication skills.  Good verbal and written English or other second language skills.  Strong understanding of GLP, FDA regulations, and data management principles.  Excellent organizational, communication, and problem-solving skills.  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. Experiences  1–2 years of experience in clinical research, laboratory operations, or project coordination (internship experience in CROs/pharma acceptable).  Familiarity with FDA/EMA/NMPA regulations and ICH guidelines is preferred. Certifications preferred:  PMP (Project Management Professional) or PRINCE2 certification (preferred).  GCP (Good Clinical Practice) training certificate (preferred).