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SalaryXenon 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. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.
What We Do:
We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship XEN1101 program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our XEN1101 Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our XEN1101 epilepsy program includes multiple Phase 3 Clinical Trials in patients with focal onset seizures and primary generalized tonic clonic seizures. In 2024, we are planning to initiate a Phase 3 XEN1101 program in major depressive disorder, based on topline data from our XEN1101 Phase 2 “X-NOVA” Clinical Trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.
About the Role:
We are seeking a Clinical Trial Associate 1 to join our team. The Clinical Trial Associate 1 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 1 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 Vice President, Trial Operations and will be located in the Boston, MA, USA location.
RESPONSIBILITIES:
- 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 file (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
Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
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.
