Job Title: Clinical Trial Manager
Location: Newark, California • Waltham, Massachusetts • Remote (preferred Fremont/Boston hybrid)
Company: Ardelyx
Employment Type: Full-time
Industry: Biopharmaceuticals / Clinical Research
Salary Range: $126,000–$154,000 per year + bonus + equity
Posting Date: [April 2025]
Position Summary
Ardelyx is seeking a Clinical Trial Manager to oversee and manage all operational aspects of one or more clinical trials from planning through completion. This role ensures studies are executed within budget, on schedule, and in accordance with ethical and regulatory standards, prioritizing patient safety throughout.
Key Responsibilities
Lead full-cycle clinical study execution including startup, enrollment, conduct, and closure.
Collaborate with CROs and vendors on study startup activities and documentation.
Review and manage critical study documents such as informed consent forms, monitoring plans, and site manuals.
Ensure adherence to study timelines, deliverables, and budget management.
Support system setup and user acceptance testing (EDC, IRT, ePRO, etc.).
Coordinate vendor oversight including labs, eCOA, ECGs, and specialty services.
Prepare dashboards, trackers, and status reports for study teams and senior leadership.
Build positive working relationships with investigators and site staff.
Qualifications
Bachelor’s degree in Life Sciences, Nursing, or related field (Master’s or certification like CCRA/CCRP preferred).
5+ years of clinical trial management or clinical research experience.
Deep knowledge of GCP, ICH, FDA guidelines, and clinical operations.
Strong project and vendor management capabilities.
Proficient in CTMS, EDC, and other clinical technologies.
Excellent communication, leadership, and problem-solving skills.
Willingness to travel occasionally; remote candidates welcome with preference for hybrid availability.
Benefits & Perks
Competitive salary with annual bonus and equity eligibility.
401(k) with employer match.
Generous parental and living organ/bone marrow leave.
Health, dental, vision, disability, and life insurance.
Flexible PTO and 11+ paid holidays including a Winter Holiday shutdown.
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