Ardelyx, Inc. · 20 hours ago
Clinical Trial Manager
Newark, CA
Full-time
Hybrid
Senior Level
$136K/yr - $160K/yr
5+ years expArdelyx, Inc. is a biopharmaceutical company dedicated to developing innovative medicines for unmet medical needs. The Clinical Trial Manager is responsible for overseeing the operational aspects of clinical trials, ensuring they are conducted ethically, on time, and in compliance with regulatory requirements while maintaining high standards of patient safety and data integrity.
BiotechnologyHealth CareMedical
Responsibilities
Provide 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 Report (CSR)
Lead study start-up activities in collaboration with CROs and investigational sites, including oversight of clinical document development and site activation activities
Manage day-to-day study execution, ensuring adherence to timelines, milestones, budgets and quality standards
Contribute to and review study plans, timelines, and operational deliverables; proactively identify risks and implement mitigation strategies to ensure successful study outcomes
Prepare, review and/approve study-related documents including but not limited to Informed Consent Forms, CRFs, Monitoring Plans, Laboratory Manuals, Patient Diaries, Clinical Site Procedures Manual and CRF Completion Guidelines)
Implement risk management and mitigation strategies, prioritizing tasks and issues to ensure successful program/study objectives
Participate in and support user acceptance testing (UAT) for clinical systems, (e.g., EDC IRT), including contribution to system requirements and validation activities
Oversee vendor performance and relationships including CROs, central laboratories, and contribute to or lead the systems set-up/management, EDC/IRT, and specialty services (ePRO, ECG, imaging etc.)
Ensure compliance with GCP, applicable regulations, SOPs, and study-specific procedures throughout the trial lifecycle
Track, analyze and communicate study progress, risks and key metrics to the Study Lead and senior management, including development and maintenance dashboards and trackers
Represent Clinical Operations professionally, fostering productive relationships with investigators, CRO partners, vendors and internal cross functional teams
Qualification
Required
Bachelor's degree in Life Sciences, Nursing, or a related field with 5+ years of experience in clinical trial management or related clinical research roles; equivalent experience may be considered
Demonstrated knowledge of current clinical trial processes, GCP, ICH guidelines and regulatory requirements
Strong project management skills, including managing of timelines, budgets, and cross-functional resources
Excellent written and verbal communication with the ability to lead cross-functional teams and external partners
Proven problem-solving skills and tools, and ability to manage complex operational issues in a fast paced environment
Experience with clinical trial systems and tools including EDC, IRT and Veeva Vault platforms
Ability to travel occasionally to clinical sites, investigator meetings, and professional conferences 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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