Senior Clinical Trial Manager

Zai Lab Limited(NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in Chinaandthe United Statesfocused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in Chinaand around the world. Our goal is to leverage our competencies and resources to positively impact human health worldwide.

Founded in 2014, our experienced team has secured partnerships with leading global biopharmaceutical companies, generating a broad and late-stage pipeline of innovative drug candidates. Based on our proven track record of success, Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to not only access the Chinese market but also find a long-term strategic partner for global clinical development.

Our unique business model builds on our in-licensed assets and innovative partnerships to expand our internal discovery and development capabilities and has created a portfolio of potential best-in-class and/or first-in-class therapies. Zai currently has four products on the market in China

Zai Lab was successfully listed on the Nasdaq Stock Market in September 2017 and completed secondary listing on Hong Kong Stock Exchange in September 2020. In 2022, Zai Lab became dual-primary listed on both the Nasdaq and the Hong Kong Stock Exchanges. Since its inception, Zai Lab has expanded significantly with several offices across China. In 2021, Zai Lab established its U.S. Headquarters in Cambridge, Massachusetts.

As of January 2022, the Company has a global team of approximately 2000 employees.

The Senior Clinical Trial Manager will lead, manage and co-ordinate the operational strategy, risk management, and overall execution of clinical trials from study start-up to close out at a global level in accordance with ICH-GCP and applicable local regulations. Collaborate with cross functional stakeholders to ensure deliverables are met in terms of quality, compliance, budget, and timing. This role may work collaboratively on one trial or across several trials to support clinical operations activities.

This position is based in our Cambridge, MA office.

• 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.

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:

• Demonstrated ability in clinical study management processes and clinical/drug development.
• Highly effective verbal and written communication…