Ardelyx, Inc. · 1 day ago
Senior Manager, Data Management
Newark, CA
Full-time
Onsite
Senior Level, Lead/Staff
$173K/yr - $211K/yr
8+ years expArdelyx, Inc. is a publicly traded biopharmaceutical company focused on developing innovative medicines for unmet medical needs. The Senior Manager, Data Management will lead day-to-day data management support for clinical studies, ensuring high-quality clinical data and overseeing the implementation of standard operating procedures.
BiotechnologyHealth CareMedical
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
Qualification
Required
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
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
Preferred
Programming experience with SQL or SAS (preferred, but not required)
Benefits
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
At least 11 paid holidays
Company
Ardelyx, Inc.
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.
201-500 employees
H1B Sponsorship
Ardelyx, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2022 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$557.68MKey Investors
HealthCare Royalty PartnersSLR Capital PartnersNew Enterprise Associates
2022-06-30Post Ipo Debt· $20M
2022-02-24Post Ipo Debt· $27.5M
2019-12-12Post Ipo Equity· $125M
Leadership Team
Mike Raab
President & CEO
David Rosenbaum
Chief Development Officer
Recent News
2026-01-09
2026-01-09
2026-01-03
Company data provided by crunchbase