Responsibilities

Full Project Lifecycle Management

• Lead the planning, start-up, execution, monitoring, and close-out phases of global Phase 1–3 clinical trials.
• Develop detailed project plans, including timelines, milestones, resource allocation, and risk-mitigation plans; track progress and update plans as needed.
• Coordinate cross-functional collaboration across Medical, Regulatory, Data Management, Statistics, PV, Supply Chain, and other functions.
• Manage external partners including CROs, SMOs, study sites, and vendors to ensure clear responsibilities and smooth communication.
• Monitor key project metrics, including enrollment rate, data quality, monitoring coverage, and budget execution.
• Identify risks and develop mitigation strategies to ensure projects are delivered on time.

Clinical Operations Execution and Compliance

• Lead or support the drafting, review, and version control of core clinical trial documents, such as ICFs, Investigator’s Brochures, clinical trial protocols, and CRFs, ensuring compliance with ICH-GCP, local regulations such as NMPA/FDA/EMA requirements, and company SOPs.
• Be responsible for the preparation, submission, and follow-up of Human Genetic Resources Administration application materials, including approvals related to the collection, preservation, and international collaboration involving Chinese human genetic resources.
• Coordinate and resolve compliance issues during the application process.
• Oversee study site start-up processes, including ethics approval, contract signing, and investigator training.
• Ensure site qualifications meet requirements and drive the timely achievement of key milestones such as first patient in.

Team Management and Capability Building

• Lead the project team, including CRAs, PM assistants, and other relevant team members.
• Define roles and responsibilities.
• Provide daily guidance and performance feedback.
• Improve the team’s professional capabilities.
• Organize project review meetings to summarize lessons learned.
• Optimize clinical operations processes and SOPs.

Qualifications

Education

• Master’s degree or above, preferably in Clinical Medicine, Pharmacy, Public Health, Biology, or other related fields.
• Outstanding candidates with a bachelor’s degree may be considered if they have more than 8 years of clinical operations experience.

Work Experience

• More than 5 years of clinical trial experience.
• More than 3 years of clinical operations project management experience.
• Independent responsibility for at least one global or regional clinical trial project.
• Experience in global Phase 1–3 clinical trial projects is required.
• Experience in autoimmune diseases, rare diseases, and other related therapeutic areas is preferred.
• Familiarity with the processes and challenges of simultaneous multi-region development, such as China, the U.S., and Europe, is required.
• Frontline clinical monitoring experience is required, preferably with a CRA background.
• Familiarity with study site operations and pain points in patient recruitment is expected.

Professional Skills

• Strong expertise in drafting and reviewing core clinical trial documents, especially ICFs.
• Familiarity with Human Genetic Resources Administration application processes and related regulations, such as the Regulations on the Administration of Human Genetic Resources, is required.
• Familiarity with ICH-GCP, GCP, and regulatory requirements of major authorities such as NMPA, FDA, and EMA.
• Strong compliance mindset.
• Proficiency in using Project, Excel, PowerPoint, and other tools for project planning and reporting.
• Ability to use English as a working language, with fluency in written and spoken communication.

Core Competencies

• Excellent project management capabilities, including time management, risk control, and resource coordination.
• Ability to remain efficient while handling multiple tasks simultaneously.
• Outstanding communication and negotiation skills.
• Ability to effectively drive cross-functional and cross-organization collaboration.
• Ability to resolve conflicts.
• Results-oriented mindset.
• Strong resilience under pressure.
• Ability to adapt to a certain level of domestic and international travel.

Preferred Qualifications

• Experience in Global Simultaneous Development projects is preferred.
• Familiarity with digital clinical trial tools, such as EDC, ePRO, and remote monitoring platforms, is preferred.

What We Offer

• A competitive compensation package, including base salary, performance bonus, and project incentives.
• Flexible working arrangements.
• Supplemental commercial insurance.
• Annual health check-ups.
• Opportunities to participate in the research and development of cutting-edge innovative drugs.
• Opportunities to collaborate with top global experts.
• A clear career development path: Project Management → Senior PM → Clinical Operations Director.