Clinical Trial Manager

About Aligos:Ready to make a difference in the lives of patients all around the world? As a leading clinical-stage biopharmaceutical company, that's our top priority. Established in 2018, Aligos became a publicly-traded company in 2020. Our employees thrive in a science-first culture with many critical domains represented on staff. Our team of respected scientists use their decades of experience to build cutting-edge pipelines of transformative treatment options that change lives. We do this by utilizing our proprietary oligonucleotide and small molecule platforms to develop novel therapeutics that address critical unmet needs in liver and viral diseases-such as MASH, COVID-19, and Chronic Hepatitis B. With three compounds already in the clinic and a diverse portfolio of assets in a variety of indications, we are poised for growth and excited for what comes next. At Aligos, you'll have an opportunity to pursue your passion among the best in the industry. It's a place where you'll be challenged, supported, and inspired. A highly collaborative, fast-paced work environment where we honor accountability, transparency, and diversity. Join us for your next challenge. Learn more about the opportunities waiting for you at Aligos. Position Summary:The Clinical Trial Manager will report directly to the Head of Clinical Operations and will be responsible for the operational implementation or support of one or more clinical trials. This individual will be a key member of a small clinical development team that is implementing a number of early-stage clinical programs evaluating multiple investigational drugs for the treatment for chronic hepatitis B, MASH and SARS-Cov2.Essential Functions / Responsibilities:The development and execution of high-quality, realistic, cross-functional, clinical trial plans using best practice management standards and methodologies. The support identification and selection of Service Providers (SPs) and investigational clinical sites The support development of Requests for Proposals from Service Providers. The management of Service Providers including training and oversight, and for being the primary point of contact for SPs. The drafting and coordination of reviews of study-related documents including protocols, informed consent forms, case report forms, monitoring plans, investigator brochures, and clinical study reports.The development and maintenance of study timelines and study budgetsThe coordination of the review of data listings and oversight of the preparation of interim/final clinical study reports.Contributing to the development of abstracts, presentations, and manuscripts.Monitoring and tracking clinical trial progress and upkeep of status update reports.Identification of program risks and development and implementation of mitigation strategies. Set up of (e)TMF, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages.Ensuring GCP compliance and inspection readiness are maintained throughout study conduct.Performing Sponsor quality oversight of clinical investigational staff and SPs.Performance of oversight of central laboratories and other ancillary vendors during start-up, conduct, and close-out.Coordination with CMC regarding drug forecasting and supply of study drug to investigational sites.Contribution to the development of clinical trial management best practice processes and SOPs. Contributing to department initiatives to improve the efficiency and effectiveness of the Clinical Operations group.May be responsible for mentoring less-experienced Clinical Operations staff on the study team.Required Education and Experience:Minimum of a Bachelor's degree (scientific field preferred) and/or RN degree is required.Minimum of 5 or more years of clinical monitoring and clinical operations experience within a pharmaceutical, biotechnology, or contract research organization is required.Experience of early clinical development, particularly with NASH, antiviral, or anti-infectious disease compounds is preferred.In depth knowledge of the Code of Federal Regulations related to clinical research, ICH GCP guidelines, and other applicable regulations and practices.Preferred Education and Experience: Experience with early clinical development, particularly with antiviral or anti-infectious disease compounds is preferred.Additional Eligibility Qualifications/CompetenciesMust have excellent teamwork, communication, decision-making and organizational skills plus a thorough knowledge and understanding of FDA and EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.Excellent communication, organizational, negotiation and interpersonal skills required. Ability to prioritize and handle multiple tasks and to facilitate and resolve cross-functional activities and issues required. Experience of Service Provider management is requiredThe successful candidate must be flexible and adaptable to the needs of a small company. Work Authorization/Security ClearanceAll candidates are expected to have authorization to work in the United States.Supervisory ResponsibilityThis position may require the management of contractors external to the company.Position Type and Expected Hours of WorkThis is a full-time position. Expected days and hours of work are Monday through Friday, 40 hours per week.TravelThis position is located in South San Francisco and may require approximately 10-15% travel.Other Duties:Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for their job. Duties, responsibilities and activities may change at any time with or without notice.Work EnvironmentThis position works in a standard office setting, in a facility that contains laboratory equipment.EEO Statement:Aligos Therapeutics, Inc. is an Equal Opportunity Employer. We do not discriminate against qualified applicants based upon any protected group status, including but not limited to race, religion, color, creed, sex (including breastfeeding and related conditions), gender identity/gender expression, pregnancy (including childbirth and related conditions), national origin, ancestry, age, marital status, military or veteran status, sexual orientation, genetic information, physical or mental disability or medical condition as defined by applicable equal opportunity laws. Any request for accommodation can be directed to People Operations.Benefits and Compensation Aligos Therapeutics provides a competitive benefits package that includes access to Medical, Dental, and Vision Insurance, Life Insurance, Short- and Long-Term Disability, Health Savings Account (HSA), Flexible Spending Accounts (FSA), Critical Illness, Accident, Legal and ID Theft, 401k plan, PTO, and ESPP (Employee Stock Purchase Plan). The anticipated salary range for fully qualified candidates applying for this role will be $136,000 - $159,000 (not including discretionary bonus, equity, and benefits). The final salary offered will be dependent on several factors that include but are not limited to relevant previous experience including duration and type of experience within the industry, education, and internal equity.