Ardelyx was 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), as well as early-stage pipeline candidates.

• QCs trial records according to Good Documentation Practices (GDP), applicable US and international regulations/guidelines including ALCOA and ALCOA principles and company WI and procedures.
• Maintains and manages Ardelyx’s electronic and paper Trial Master Files (TMF) in an inspection readiness state.
• Applies proper classification and metadata to essential records per the TMF Plan, TMF Index and company WIs.
• Documents, tracks and works alongside internal/external team members to resolve quality issues/findings.
• Performs eTMF/TMF archivals, transfers and migrations, as needed.
• Supports the development, management and maintenance of Clinical systems (e.g., eTMF, eISF, CTMS, etc.).
• Provides regular trial records status metrics/updates to internal and external stakeholders.
• Generates and distributes study-specific meetings minutes, as required.
• Participates in the review and updating of department plans, SOPs and WIs, as required.
• Prepares trial documentation, including Investigator Site File binders, as required.

• Bachelor’s degree or equivalent experience.
• 2-3 years of direct experience working with TMF records.
• Experience with the TMF Reference Model, GCP and GDP standards and applicable Regulatory requirements.
• Knowledge and experience with clinical and operational issues involved with clinical research.
• Recognition and understanding of clinical research documents, their contents and purpose.
• Excellent organizational skills, follow-through, and attention to detail.
• Must be able to follow SOPs and WIs and effectively triage when deviations from procedures occur.
• Excellent oral and written communication skills.
• Ability to work independently on routine assignments or under supervision on new assignments.
• Quality and timelines focused.
• Proficient in MS Office products (e.g. Excel, Power Point & Word) and eTMF system (e.g., Veeva, Medidata, Phlex).
• eISF, CTMS, SmartSheet experience would be a plus.