Clinical Trial Manager
Clinical Trial Manager
Posted on :
10-04-2025
Employer Active
1 Vacancy
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Job Description
Description
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover develop and commercialize innovative firstinclass 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 foroverseeing 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 of clinical studies on one or more clinical programs from initial study synopsis through final project deliverables (study setup enrollment conduct database lock final TLFs CSR etc.
- Lead study startup activities with CROs and clinical sites including working closely with CRO to complete template clinical documents
- Manage the implementation ontime and conduct of clinical studies contributing to and tracking milestones and timelines.
- Prepare and/or review/approve studyrelated 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 setup/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:
- Bachelors degree in Life Sciences Nursing or a related field with 5 years of experience in clinical trial management or related clinical research positions
- Masters degree and clinical research certification (e.g. CCRA CCRP) highly desirable
- Indepth 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 problemsolve 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 fulltime position is $126000$154000. 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.
Required Experience:
Manager
Employment Type
Full-Time
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