Description Ardelyx is a publicly-traded biopharmaceutical company founded with a mission to discover, develop, and commercialize innovative first-in-class medicines that address significant unmet medical needs and advance patient care.
Ardelyx plans to launch the company’s first-in-class, novel mechanism therapy, approved for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults, in the second quarter of 2022.
Ardelyx is also pursuing approval of tenapanor, an investigational first-in-class phosphate absorption inhibitor that has completed three successful phase 3 trials.
Clinical Document Specialist (Contractor role)Purpose of the role:We are seeking a Clinical trial professional with excellent attention to detail and organizational skills to assist with the management of trial related documents based on applicable US (and international, if applicable) regulations and guidelines as well as company Work Instructions, and procedures.
Position Responsibilities:The Clinical Document Specialist responsibilities and duties include but are not limited to:Work with the Clinical team in maintaining and managing activities for Ardelyx’s electronic and if needed, paper Trial Master Files (TMF).Classify documents according to the standardized TMF Reference Model.Enter required document metadata in an electronic TMF.QC trial documents according to Good Documentation Practices (GDP), applicable US and international regulations/guidelines including ALCOA and ALCOA and company WI and procedures.Document and track trial document findings through resolution.Approve documents and confirm Inspection Readiness.Work alongside cross-functional teams to resolve trial document findings.Create and provide trial document status metrics through spreadsheets, reports and/or dashboards, as needed.
Assist with TMF archival, transfer and migration activities, as needed.
Assist the Clinical team with the day-to
– day management of clinical trials in Veeva and/or Clinical Trial Management System (CTMS), as needed.Assist with the management of on-site and off-site storage of archived TMFs to ensure prompt retrieval of archived documents when needed.Attend departmental and study-specific meetings and discussions, and record minutes, as required.Position Requirements: Bachelor’s degree or equivalent experience.
1-2 years of direct experience working with TMF documents.
Knowledge and experience with clinical and operational issues involved with clinical research.
Experience with TMF DIA Reference Model, GCP and GDP standards and applicable Regulatory requirements.
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 standard operating procedures 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.
Experience in MS Office products (e.g.
Excel, PowerPoint & Word).
Experience with Veeva Vault eTMF & SmartSheet is a plus.Ardelyx currently maintains a policy requiring all employees to be fully vaccinated against COVID-19 in accordance with CDC guidelines.
Newly hired employees must be fully vaccinated prior to their employment start date.
Ardelyx is an equal opportunity employer and will provide reasonable accommodations for those unable to be vaccinated who qualify for exemption in accordance with applicable law.