What are the responsibilities and job description for the Clinical Trial Manager position at Ardelyx?
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 submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
Purpose of Role:
The Clinical Trial Manager is responsible for overseeing all aspects of a clinical trial, from initial planning and design to data analysis and reporting, ensuring the study is conducted ethically, on time, within budget, and in compliance with regulatory standards, while prioritizing patient safety throughout the process.
Responsibilities:
- Complete project milestones to oversee the overall operational execution of clinical studies on one or more clinical programs from initial study synopsis through final project deliverables (study set-up, enrollment, conduct, database lock, final TLFs, CSR, etc.)
- Lead study start-up activities with CROs and clinical sites, including working closely with CRO to complete template clinical documents
- Manage the implementation, on-time execution, and conduct of clinical studies, contributing to and tracking milestones, and timelines.
- Prepare and/or review/approve study-related documents (e.g., Informed Consent Forms, CRFs, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
- Implement risk management and mitigation strategies, prioritizing tasks and issues to ensure successful program/study objectives
- Participate in activities related to user acceptance testing (UAT) of clinical systems, such as EDC and interactive response technology (IRT) and contribute to authoring system requirements
- Manage vendor relationships and contribute to or lead the systems set-up/management, including EDC, IRT, Central Laboratories, and specialty services (ePRO, ECG, etc.)
- Track and communicate program/study progress to the Study Lead and Senior Management, with the ability to create and update detailed dashboards and trackers
- Represent the department professionally, building and establishing positive relationships with investigators and all other study personnel
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, or a related field with 5 years of experience in clinical trial management or related clinical research positions
- Master’s degree and clinical research certification (e.g., CCRA, CCRP) highly desirable
- In-depth knowledge of current clinical trial processes, GCP, and regulatory requirements
- Strong project management skills, including managing timelines, budgets, and resources
- Excellent communication and leadership skills
- Ability to problem-solve and handle complex issues efficiently
- Familiarity with clinical trial management software and tools (e.g., EDC systems, eTMF)
- May require occasional travel to clinical sites, investigator meetings, and professional meetings
- Remote location will be considered but potential for weekly office attendance is preferable (Fremont/Boston)
The anticipated annualized base pay range for this full-time position is $126,000-$154,000. 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.
Salary : $126,000 - $154,000
