Zai Lab · 2 days ago
Senior Clinical Trial Manager (Office Based - South SF 3X/wk)
South San Francisco, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$177K/yr - $203K/yr
8+ years expZai Lab is a patient-focused, innovative biopharmaceutical company dedicated to developing therapies for significant unmet medical needs. The Senior Clinical Trial Manager will lead the operational strategy and execution of clinical trials globally, ensuring compliance with regulations and collaboration with various stakeholders.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Lead and coordinate a cross-functional study team to ensure the clinical trial progresses as planned
Accountable for the overall operational strategy and delivery (e.g., country and site selection/start-up, site contracts, patient recruitment and retention, etc.) of assigned clinical trials; ensuring that study-level deliverables are met according to timeline, budget, and quality requirements
Participates in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central/specialty lab, ECG, imaging, PRO specifications, drug supply, biomarker/sample management plans, TMF, and CSRs
Drafts and implements study plans including; vendor oversight, risk, quality, safety, communication, trial monitoring, and TMF
Ensures TMF creation and QC completion
Supports EDC, IxRS, and CTMS systems and data maintenance
Tracks budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions
Accountable for the study budget and manages assigned vendor budget(s); communicates variances in actual versus forecasted spend in vendor budgets and presents an action plan for resolution
Drives the selection of vendors (participates in the Request for Proposal (RFP) process) on a global scale
Oversees delegated outsourced activities to ensure CRO and vendor delivery against the contracted scope of work
Leads the Investigator Meeting preparation and execution with the support from cross-functional team members
Stays current on relevant therapeutic area knowledge and clinical research best practices
Ensures study adherence to ICH/GCP and company SOPs
Qualification
Required
Undergraduate degree in a scientific or health-related discipline
Minimum of 8 years relevant experience of which 5 years are clinical experience in the pharmaceutical industry, including 3 years in study management or equivalent combination of education, training, and experience
Ability to work across several time zones
Preferred
Prior people management experience
Demonstrated ability in clinical study management processes and clinical/drug development
Highly effective verbal and written communication skills; effectively deliver key messages; aptitude to independently communicate with teams and stakeholders
Ability to effectively lead projects and persuade and influence peers; ability to build trusting and collaborative relationships globally
Experience with effective vendor management
Strong customer focus with investigators, functional peers, vendors, etc
Excellent planning and organizational skills
Working knowledge of international regulatory and ICH Good Clinical Practice guidelines
Maintains the highest standards of integrity and ethics
Benefits
Sign-on bonus
Restricted stock units
Discretionary awards
Full range of medical, financial, and/or other benefits
401(k) eligibility
Various paid time off benefits
Vacation
Sick time
Parental leave
Company
Zai Lab
Zai Lab brings transformative medicines for cancer, autoimmune, and infectious diseases to patients in China and around the world.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.28BKey Investors
OrbiMedAdvantech CapitalQiming Venture Partners
2025-10-16Post Ipo Debt· $42.1M
2024-11-14Post Ipo Equity· $230M
2021-04-19Post Ipo Equity· $857.5M
Leadership Team
Yajing Chen, PhD
Chief Financial Officer
Ann Beasley
Chief Compliance Officer
Recent News
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