Clinical Trial Manager

Description

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients.


Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive.


We foster an inclusive environment where employees are respected, supported, and empowered to make an impact - both within our company and in the lives of patients we serve.

Position Summary (Hybrid Location):

The Clinical Trial Manager (CTM) is responsible for the end-to-end operational oversight of clinical trials, from study planning through close-out and reporting. This role ensures trials are executed ethically, on time, within budget, and in full compliance with applicable regulatory requirements and Good Clinical Practice (GCP), while maintaining the highest standards of patient safety and data integrity. 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 toInformed 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

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 roles; equivalent experience may be considered
• Master's degree and clinical research certification (e.g., CCRA, CCRP) strongly preferred
• 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 (Newark or Waltham)

The anticipated annualized base pay range for this full-time position is $136,000-$160,000. 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.