Xenon Pharmaceuticals Inc.
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Clinical Trial Associate 1 or 2
role at
Xenon Pharmaceuticals Inc.
Overview Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. The Clinical Trial Associate 1 or 2 will support the Clinical Operations team with project-specific activities related to the conduct of clinical trials, providing administrative and project tracking support to help ensure efficient trial execution.
This is a hybrid role based in Boston, MA, USA (Needham office) and requires a minimum of 2 days per week in the office. The level of the position will be commensurate with the candidate’s education and industry experience.
Responsibilities
Review clinical documents (Protocols, Informed Consents, study plans) and assist with start-up activities, including maintenance of study reference manuals, site tools, templates, source documents, and guidelines
Collaborate with CROs, vendors, and clinical sites to perform day-to-day trial activities, generate management status reports, track sample collection/shipment/analysis, and coordinate distribution of clinical trial supplies, equipment, and kits
Assist with review and tracking of regulatory documents for site activation, including site/country specific informed consent forms
Develop and regularly update clinical trial tracking tools to monitor progress, including patient recruitment, trial supplies, and trial documentation
Support the study master file (eTMF) by filing and maintaining sponsor documents, reviewing eTMF plans, and performing quality oversight of CRO eTMF
Track and process invoices and authorized payments to vendors and study sites
Attend study team and department meetings, assist with logistics, prepare agendas and minutes, and collate materials
Prepare shipment requests to 3rd party laboratory vendors, track sample receipt, and generate summary reports for the clinical trial manager
Monitor timelines, budgets, and clinical trial materials and supplies
Assist with Investigator meetings planning and preparation
Prepare documentation for due diligence, audits, and regulatory inspections
Perform QC reviews of SOPs, protocols, informed consent, and other study documents
Participate in special projects to improve processes, tools, and systems
Develop understanding of clinical trial research, GCP guidelines, and FDA regulations relevant to the role
Adhere to company policies and Code of Business Conduct and Ethics
Other duties as assigned
Qualifications
Bachelor’s degree in health sciences or related field
Clinical Trial Associate 1: 2+ years of relevant pharma/biotech or CRO experience (or equivalent)
Clinical Trial Associate 2: 4+ years of relevant pharma/biotech or CRO experience (or equivalent)
Ability to manage multiple clinical projects and priorities
Knowledge of clinical trial processes and ICH-GCP guidelines
Ability to work independently and as part of a multidisciplinary team
Excellent written and verbal communication and organizational skills
Proficient in Microsoft Word, Excel, PowerPoint, and related tools
Strong interest in clinical trials and willingness to take on increasing responsibilities
Compensation and Benefits The base salary range for this role is
$76,350 to $92,575 USD . We will consider above this range for exceptional candidates. Base salary is determined by factors including education, experience, and internal equity.
Our Total Rewards program includes base salary, target bonus, and stock options, plus a full range of benefits including medical, dental, vision, disability and life insurance, 401(k) with company matching, and more. Xenon also supports time off, including vacation, personal days, sick days, and year-end shutdowns, with opportunities for training and professional development.
As part of our hiring process, Xenon conducts background checks for finalist candidates. US positions only: Xenon participates in E-Verify where applicable. More information is available on the E-Verify program.
To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, only those chosen for interview will be contacted.
#J-18808-Ljbffr
Clinical Trial Associate 1 or 2
role at
Xenon Pharmaceuticals Inc.
Overview Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. The Clinical Trial Associate 1 or 2 will support the Clinical Operations team with project-specific activities related to the conduct of clinical trials, providing administrative and project tracking support to help ensure efficient trial execution.
This is a hybrid role based in Boston, MA, USA (Needham office) and requires a minimum of 2 days per week in the office. The level of the position will be commensurate with the candidate’s education and industry experience.
Responsibilities
Review clinical documents (Protocols, Informed Consents, study plans) and assist with start-up activities, including maintenance of study reference manuals, site tools, templates, source documents, and guidelines
Collaborate with CROs, vendors, and clinical sites to perform day-to-day trial activities, generate management status reports, track sample collection/shipment/analysis, and coordinate distribution of clinical trial supplies, equipment, and kits
Assist with review and tracking of regulatory documents for site activation, including site/country specific informed consent forms
Develop and regularly update clinical trial tracking tools to monitor progress, including patient recruitment, trial supplies, and trial documentation
Support the study master file (eTMF) by filing and maintaining sponsor documents, reviewing eTMF plans, and performing quality oversight of CRO eTMF
Track and process invoices and authorized payments to vendors and study sites
Attend study team and department meetings, assist with logistics, prepare agendas and minutes, and collate materials
Prepare shipment requests to 3rd party laboratory vendors, track sample receipt, and generate summary reports for the clinical trial manager
Monitor timelines, budgets, and clinical trial materials and supplies
Assist with Investigator meetings planning and preparation
Prepare documentation for due diligence, audits, and regulatory inspections
Perform QC reviews of SOPs, protocols, informed consent, and other study documents
Participate in special projects to improve processes, tools, and systems
Develop understanding of clinical trial research, GCP guidelines, and FDA regulations relevant to the role
Adhere to company policies and Code of Business Conduct and Ethics
Other duties as assigned
Qualifications
Bachelor’s degree in health sciences or related field
Clinical Trial Associate 1: 2+ years of relevant pharma/biotech or CRO experience (or equivalent)
Clinical Trial Associate 2: 4+ years of relevant pharma/biotech or CRO experience (or equivalent)
Ability to manage multiple clinical projects and priorities
Knowledge of clinical trial processes and ICH-GCP guidelines
Ability to work independently and as part of a multidisciplinary team
Excellent written and verbal communication and organizational skills
Proficient in Microsoft Word, Excel, PowerPoint, and related tools
Strong interest in clinical trials and willingness to take on increasing responsibilities
Compensation and Benefits The base salary range for this role is
$76,350 to $92,575 USD . We will consider above this range for exceptional candidates. Base salary is determined by factors including education, experience, and internal equity.
Our Total Rewards program includes base salary, target bonus, and stock options, plus a full range of benefits including medical, dental, vision, disability and life insurance, 401(k) with company matching, and more. Xenon also supports time off, including vacation, personal days, sick days, and year-end shutdowns, with opportunities for training and professional development.
As part of our hiring process, Xenon conducts background checks for finalist candidates. US positions only: Xenon participates in E-Verify where applicable. More information is available on the E-Verify program.
To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, only those chosen for interview will be contacted.
#J-18808-Ljbffr