Clinical Trial Manager

Ardelyx; Waltham (MA); Hybrid; USD 126,000 - 154,000; Full time

Job summary

An established industry player is seeking a Clinical Trial Manager to oversee the complete lifecycle of clinical trials, ensuring ethical conduct and regulatory compliance. This pivotal role involves managing project milestones, vendor relationships, and study documentation, all while prioritizing patient safety. The ideal candidate will bring significant experience in clinical trial management, strong project management skills, and a commitment to excellence. Join this innovative firm and contribute to groundbreaking therapies that address unmet medical needs while enjoying a competitive salary and comprehensive benefits package.

Benefits

401(k) plan with employer match

12 weeks of paid parental leave

Flexible time off

Annual Winter Holiday shutdown

Health plans (medical, dental, vision)

Life insurance and disability

Equity incentive plans

Paid holidays

Living organ and bone marrow leave

Qualifications

• 5+ years of experience in clinical trial management or related clinical research positions.
• In-depth knowledge of current clinical trial processes, GCP, and regulatory requirements.
• Strong project management skills, including managing timelines, budgets, and resources.

Responsibilities

• Oversee operational execution of clinical studies from initial study synopsis to final deliverables.
• Manage vendor relationships and lead systems setup/management.
• Track and communicate program/study progress to the Study Lead and Senior Management.

Skills

Clinical Trial Management

Project Management

Communication Skills

Problem-Solving

Regulatory Compliance

Leadership Skills

Education

Bachelor's degree in Life Sciences

Master's degree in a related field

Clinical research certification (e.g., CCRA, CCRP)

Tools

EDC systems

eTMF

Job description

Description

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 approved 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 or equivalent experience
• 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.