Clinical Trial Management Associate

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.

• Manage and track timeline relating to CRO and third-party vendor activities to ensure timely delivery of services and materials
• Work with sites, Contract Research Organizations (CROs) and field CRAs to assist with driving start-up, study conduct, and/or close out activities
• Track trial progress and ensure all clinical trial activities are documented and reported to management. Assist in generating periodic progress reports for stakeholders
• Maintain study documentation, ensuring accuracy and completeness, including essential documents, regulatory submissions, and trial logs
• Contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans, study communications and presentations
• Participate in the development of case report forms and in the EDC and IXRS specification process
• Prepare agendas, minutes and tracks action items

• BA, BS, AA or AS degree in life sciences, nursing or related disciplines with 3+ years of experience in clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements or equivalent experience
• Demonstrate basic understanding of medical terminology and clinical activities in relation to execution of Clinical Development Plan
• Proficiency in MS Office products (e.g. Excel, Power Point & Word)
• Strong verbal and written communication skills
• Ability to work independently in a fast-paced environment with strong attention to detail
• Collaborative style, with the ability to build and enhance partnership across the organization

The anticipated annualized base pay range for this full-time position is $93,000 - $113,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.

Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision),life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.

Ardelyx is an equal opportunity employer.