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.
Position Summary:
The Senior Manager, Data Management serves as the Lead DM and oversees day-to-day DM support from direct reports and external vendors, including Contract Research Organizations (CROs) and contractors, for Ardelyx’s clinical studies across multiple therapeutic areas. This role works closely with the Head of Biometrics, Biostatistics, Statistical Programming, Clinical Operations, Clinical Safety, and Medical to ensure high-quality, reliable, and compliant clinical data. As the DM Group Lead within Biometrics, the Sr. Manager of DM also develops, implements, and maintains standard operating procedures (SOPs) and work instructions that govern DM activities at Ardelyx.
Responsibilities:
- Serve as the in-house Lead Data Manager for Ardelyx clinical studies across multiple therapeutic areas
- Design electronic Case Report Forms (eCRFs) and perform hands-on creation and configuration of eCRFs within the Electronic Data Capture (EDC) system
- Develop, update, and maintain study-specific DM documentation, including Data Management Plans (DMPs), eCRF Completion Guidelines (eCCG), and Edit Check Specifications
- Perform and coordinate User Acceptance Testing (UAT) for the EDC system
- Generate, process, track, and resolve data queries in a timely manner and perform data reconciliation across multiple clinical data sources (e.g., EDC, ePRO, IRT, central lab, safety database)
- Perform database freeze and lock activities, and manage database unlocks as required.
- Oversee medical coding activities using standardized dictionaries (MedDRA, WHODrug), whether conducted internally or by external vendors, ensuring accuracy and compliance
- Lead the implementation and maintenance of CDASH-based data collection standards to ensure consistency and facilitate development of SDTM domains
- Participate in clinical trial budget planning and vendor selection
- Manage the DM group and leverage resources for all DM deliverables
- Oversee DM activities conducted by external vendors, ensuring adherence to timelines, quality standards, and contractual obligations
- Develop, implement, and maintain SOPs and work instructions that govern DM activities at Ardelyx
Qualifications:
- Bachelor’s degree, advanced degree preferred, in a biomedical science or related field with 8 - 10 years of related experience in a pharmaceutical, biotech, or CRO setting, or equivalent experience
- Strong knowledge of ICH, FDA, GCP, and HIPAA regulations and guidelines; familiarity with EDC systems (e.g., Medidata RAVE) and industry-standard coding dictionaries (MedDRA and WHODrug)
- Proficient in all aspects of DM from study start-up through study close-out, including eCRF design, development of DM documentation (e.g., DMP and eCCG), data validation, discrepancy management, data reconciliation, external data transfers, and database freeze/lock/unlock procedures
- Knowledge of CDASH standards and their application to eCRF design and data collection
- Programming experience with SQL or SAS (preferred, but not required)
- Experience managing DM support from external vendors, particularly CROs
- Ability to work both independently and collaboratively in a cross-functional team environment
- Strong organizational and problem-solving skills with great attention to detail and the ability to manage multiple priorities
- Strong verbal and written communication skills
The anticipated annualized base pay range for this full-time position is $173,000-$211,000. 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.
