Based in Menlo Park, CA since 2018, Zai Lab U.S. is focused on discovering and developing novel therapies for the treatment of cancer and inflammatory diseases. We are an innovative, research-based, commercial stage company, with over 850 employees worldwide and a diversified and strong pipeline poised for continued growth. This is an exciting time for us as we build our R&D Drug Discovery team and advance our global pipeline, aiming to produce 1-2 global INDs per year.
At Zai (NSDAQ: ZLAB), we are working to generate optimum therapeutics for significant diseases affecting peoples throughout the world. Transforming lives of patients by identifying new and smarter ways to treat and cure disease is out mission. We bring together the best minds from all over the world to pursue our goals.
The Clinical Trial Manager/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.
Major Responsibilities and Duties:
Lead and coordinate a cross-functional study team to ensure the clinical trial progresses as planned.
Accountable for the overall operational 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.
Provides input to 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.
Participates in 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.
Undergraduate degree in a scientific or health-related discipline.
Minimum of 5 years relevant clinical experience in the pharmaceutical industry, including 2 years in study management experience, or equivalent combination of education, training, and 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.
Experience with effective vendor management.
Strong customer focus with investigators, functional peers, vendors, etc.
Excellent planning and organizational skills.
Ability to build trusting and collaborative relationships globally.
Working knowledge of international regulatory and ICH Good Clinical Practice guidelines.
Willingness to travel domestically and internationally and work across cultures.
Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.