Xenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is committed to delivering innovative medicines to provide a brighter future for patients suffering from neurological disorders.
At Xenon, we are advancing an exciting pipeline of neurology-focused therapies, with a particular emphasis on novel treatments for both adult and pediatric patients with epilepsy. XEN496 is currently being evaluated in the Phase 3 “EPIK” clinical trial in young patients with KCNQ2-DEE, a rare and severe form of childhood epilepsy. Late-stage development plans are also underway for our XEN1101 program, building upon the compelling data from the Phase 2b “X-TOLE” study in adult patients with focal epilepsy. We are also proud of the leading-edge science coming out of our discovery labs, with many early-stage research programs underway. In addition to Xenon’s proprietary programs, we have ongoing collaborations with our valued pharmaceutical partners. With a healthy balance sheet to support our growth plans, we continue to build a fully-integrated, premier neuroscience company with strong discovery, development, and commercial operations.
Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver new medicines for patients in need. Building and maintaining a respectful, collaborative, inclusive, and productive culture is a priority for us. We are looking for great people who thrive in a fast-paced, dynamic work environment to join our team during this transformative time for Xenon. To learn more about job opportunities at Xenon, please visit www.xenon-pharma.com.
We are seeking a Clinical Trial Associate to join our team. The Clinical Trial Associate will be an individual responsible for supporting Clinical Operations team members with project-specific support related to the conduct of clinical trials activities. The Clinical Trial Associate will assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administrative and project tracking support.
This position reports to the Executive Director, Trial Operations and will be located in either the Vancouver, BC, Canada or Boston, MA, USA location.
Work with the clinical operations team in review of clinical documents (Protocols, Informed Consents, study plans and related documents). Participate in study start up activities including preparation and maintenance of study reference manuals, site tools, templates, source documents and guidelines.
Collaborate with CROs, vendors and clinical sites in performing the day-to-day activities of a clinical trial, including generating management status reports, tracking the collection, shipment, and analysis of all study samples and coordination of the distribution of clinical trial supplies, equipment, and laboratory kits.
Assist with the review and tracking of key regulatory documents required for site activation, including the tracking and review of site/country specific informed consent forms.
Develop and regularly update clinical trial tracking tools and systems that provide metrics and tracking of a clinical trial’s progress, including patient recruitment, trial supplies and trial documentation.
Support the study specific trial master file by filing and maintaining electronic trial master fie (eTMF) for sponsor documents, review of eTMF plans and perform quality oversight of CRO eTMF throughout trial.
Track and process approved invoices and authorized clinical trial payments to selected vendors and study sites.
Attend study team and department meetings while assisting with meeting logistics (scheduling, room and equipment set up, attendance tracking), agenda preparation, meeting minutes, and collating materials for meetings.
Compile shipment request to 3rd party laboratory vendors, track and ensure samples received at vendors, follow up with sites/CRO for missing samples, and prepare/provide summary reports to clinical trial manager as requested.
Assist in monitoring of timelines, budgets, and clinical trial materials and supplies.
Assist in the planning and preparation for Investigator meetings.
Assist with document preparation for due diligence, audits and/or regulatory inspections.
Complete quality control (QC) review of SOPs, protocols, informed consent, and other relevant study documents.
Participate in special projects to continuously improve processes, tools and systems.
Develop an understanding of clinical trial research through exposure to research protocols, the drug development process, clinical meetings, Company Standard Operating Procedures (SOPs), and Food and Drug Administration (FDA) guidelines as related to Good Clinical Practices (GCP).
Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
Other duties as assigned.
Bachelor’s degree in health sciences or related field with 2+ years of relevant experience in a pharmaceutical/biotechnology or CRO environment, or equivalent combination of education and experience.
Ability to work on multiple clinical projects and manage priorities effectively
Knowledge of clinical trial processes and ICH-GCP guidelines
Ability to work both independently and as part of a multidisciplinary team
Excellent written communication, oral communication, and organizational skills are required
Proficient computer skills using Microsoft Word, Excel, PowerPoint, etc.
Strong interest in clinical trials and initiative to learn and participate in projects of increasing responsibility
To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.
We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders.
Our novel product pipeline addresses areas of high unmet medical need, with a focus on epilepsy.