Senior Clinical Trials Manager

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 South San Francisco CA 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.

Qualifications :

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.

Additional Information :

The pay range for this position at commencement of employment is expected to be between $172K and $191K/year; however base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and experience. The total compensation package for this position may also include other elements including a sign-on bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

At Zai we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels 58% of our employees are women and 54% of our management positions are held by women. We are committed to the health of patients and our planet. Thats why our environmental protection social responsibility and corporate governance strategy called Trust for Life is integrated within our business.

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.

Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context.  Privacy Notice available upon request.