Ardelyx, Inc. · 12 hours ago
Senior Clinical Trial Manager
Newark, CA
Full-time
Hybrid
Senior Level
$163K/yr - $190K/yr
7+ years expArdelyx, Inc. is a publicly traded commercial biopharmaceutical company focused on innovative medicines. The Senior Clinical Trial Manager will provide strategic and operational leadership for clinical trials, ensuring they are conducted ethically, on time, and in compliance with regulations.
BiotechnologyHealth CareMedical
Responsibilities
Provide senior-level operational leadership for one or more clinical studies or programs, overseeing execution from initial study synopsis through final deliverables, including study start-up, enrollment, conduct, database lock, statistical outputs (TLFs), and Clinical Study Reports (CSRs)
Serve as the primary operational point of contact for assigned studies, partnering closely with the Study Lead, Clinical Operations leadership, and cross-functional teams
Lead and oversee study start-up activities in collaboration with CROs and investigational sites, including strategic oversight of clinical document development, site activation, and readiness activities
Drive study execution to ensure adherence to timelines, milestones, budgets, and quality standards; proactively identify operational risks and develop mitigation and contingency plans
Provide oversight, review, and approval of study-related documents, including Informed Consent Forms (ICFs), CRFs, Monitoring Plans, Laboratory Manuals, Pharmacy Manuals, Patient Diaries, Clinical Site Procedures Manuals, and CRF Completion Guidelines
Oversee CRO and vendor performance, including selection support, contract scope review, governance, issue escalation, and performance management across central laboratories, EDC/IRT providers, and specialty vendors (ePRO, ECG, imaging, etc.)
Lead and/or support user acceptance testing (UAT) and validation activities for clinical systems, contributing to system requirements and ensuring readiness for study conduct
Ensure inspection readiness and compliance with GCP, ICH guidelines, applicable regulations, SOPs, and study-specific procedures; support audits and regulatory inspections as needed
Develop, maintain, and present detailed study dashboards, metrics, and risk assessments; communicate study status, issues, and mitigation strategies to senior management and governance committees
Mentor and provide functional guidance to Clinical Trial Managers, Clinical Trial Associates, or other study team members, contributing to team development and operational excellence
Represent Clinical Operations internally and externally, building strong relationships with investigators, CROs, vendors, and cross-functional stakeholders
Qualification
Required
Bachelor's degree in Life Sciences, Nursing, or a related field with 7–10+ years of clinical research experience, including significant hands-on clinical trial management responsibility; equivalent experience may be considered
Demonstrated expertise in clinical trial operations, GCP, ICH guidelines, and global regulatory requirements
Proven ability to lead complex, multi-site and/or global clinical studies across multiple vendors
Strong strategic and operational project management skills, including budget oversight and resource planning
Excellent leadership, communication, and stakeholder management skills, with experience influencing cross-functional and external partners
Advanced problem-solving skills and the ability to manage ambiguity and competing priorities
Proficiency with clinical trial systems and tools, including EDC, IRT, and eTMF platforms
Willingness to travel occasionally to clinical sites, investigator meetings, and professional meetings as required
Remote work considered; preference for candidates able to attend the office weekly (Fremont or Boston)
Preferred
Master's degree and clinical research certification (e.g., CCRA, CCRP) strongly preferred
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
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
Elizabeth Grammer
Chief Legal and Administrative Officer
Recent News
GlobeNewswire
2026-01-23
2026-01-20
2026-01-20
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