Senior Clinical Trial Manager

Zai-Lab-; Cambridge (MA); On-site; USD 164,000 - 214,000; Full time

Job summary

Zai Lab Limited is seeking a Senior Clinical Trial Manager to lead and coordinate the operational strategy, risk management, and execution of global clinical trials in accordance with ICH-GCP and local regulations. The role is based in our Cambridge, MA office.

You will collaborate with cross-functional teams, manage budgets and timelines, and oversee vendor relationships to ensure quality and timely trial delivery across multiple sites and countries.

Qualifications

• Undergraduate degree in a scientific or health-related discipline.
• Minimum of 8 years relevant experience, including 5 years clinical experience in the pharmaceutical industry, with at least 3 years in study management.
• Ability to work across several time zones.

Responsibilities

• Lead and coordinate a cross-functional study team to ensure the clinical trial progresses as planned.
• Accountable for overall operational strategy and delivery (country/site start-up, site contracts, patient recruitment and retention) of assigned trials.
• Develop and finalize cross-functional documents and plans (ICFs, protocols, TMF, EDC, IxRS, CTMS).
• Draft and implement study plans including vendor oversight, risk, quality, safety, communication, and trial monitoring.

Skills

Study management

Vendor management

Budget oversight

Education

Bachelor's degree in scientific/health-related discipline

Tools

EDC

IxRS

CTMS

Job description

Zai Lab Limited(NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based inChinaandthe United Statesfocused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients inChinaand 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 ofJanuary 2022, the Company has a global team of approximately 2000 employees.

Job Description

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.

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:

• 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 $164K and $214K/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. That's 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 aPrivacy Noticewhich sets forth our policies and practices for handling the information we collect and use in the employment context. Privacy Notice available upon request.