- 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
- 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 (Fremont or Boston)
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The Clinical Trial Manager (CTM) is responsible for the end-to-end operational oversight of clinical trials. · Provide operational leadership for one or more clinical studies or programs. · Manage day-to-day study execution, ensuring adherence to timelines, milestones, budgets an ...
Newark $136,000 - $160,000 (USD)1 month ago
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· 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 Unit ...
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The Senior Clinical Trial Manager provides strategic and operational leadership for the execution of clinical trials across one or more clinical programs. · Provide senior-level operational leadership for one or more clinical studies or programs. · Serve as the primary operationa ...
Newark $163,000 - $190,000 (USD)1 month ago
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The Senior Clinical Trial Manager (Senior CTM) provides strategic and operational leadership for the execution of clinical trials across one or more clinical programs. · ...
Newark, CA1 month ago
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· 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 Unit ...
Newark, California1 day ago
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· TheClinicalTrialManagerisahighlyautonomousandexperiencedclinicaloperationsprofessionalresponsibleforallaspectsofClinicalTrialManagementforgloballestudies. · Overseestudy scopeworkwiththeinternalSummitfunctionalleads,CROandvendorstorensurethatoverallprojectobjectivesaremet · In ...
Palo Alto $135,500 - $150,000 (USD)3 weeks ago
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+ Clinical Trial Manager + · We are seeking a dynamic and experienced Clinical Trial Manager to join our Clinical Operations team.You will support day-to-day execution of one or more clinical studies (Phase 1–3), partnering closely with the Sr. CTM/Clinical Operations lead and cr ...
Palo Alto $133,000 - $161,000 (USD)2 weeks ago
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We are seeking a dynamic and experienced Clinical Trial Manager to join our Clinical Operations team.You will be responsible for supporting day-to-day execution of one or more clinical studies (Phase 1–3), partnering closely with the Sr. CTM/Clinical Operations lead and cross-fun ...
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This is a unique opportunity for an experienced Clinical Operations Professional who has technical expertise in managing Phase I-III clinical trials in an industry setting. · Clinical operations functional activities related to the execution of assigned clinical trials based upon ...
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About Soleno Therapeutics Inc · Soleno is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases based in Redwood City, CA. · At Soleno, we are driven by the unique and multi-faceted needs of the PWS c ...
Redwood City $145,000 - $185,000 (USD)3 days ago
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About Soleno Therapeutics Inc · Soleno is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases based in Redwood City, CA. · At Soleno, we are driven by the unique and multi-faceted needs of the PWS c ...
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The Clinical Trial Manager is accountable for successfully delivering the full scope of study activities including site activation, patient recruitment, study monitoring and site and vendor management. · Lead overall operational execution of a global clinical study from initial s ...
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The Clinical Trial Manager/Senior Clinical Trial Manager reports to the Vice President, Clinical Operations and is responsible for the end-to-end operational leadership and execution of Soleno's clinical programs across all phases of development. · Leads operational planning and ...
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The Clinical Trial Manager will independently manage all clinical aspects of a medium to large clinical study or up to two smaller clinical studies. · This role will work closely with cross-functional teams, vendors, sites, and CRO (when applicable) to ensure compliance with prot ...
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Jasper is a biotechnology company focused on enabling cures by targeting mast cells and stem cells. Our mission is to make safer and potentially curative therapy possible for most patients in need. · We are bringing together a team of biotech veterans, leading academic institutio ...
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As a key member of the clinical operations team, this position will support all aspects of Adicet Bio's clinical trials. · ...
Redwood City, CA1 month ago
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As a clinical trial manager at Adicet Bio Inc. in Redwood City CA you will support all aspects of the company's clinical trials including site activation patient recruitment study monitoring and site and CRO vendor management. · ...
Redwood City, CA1 month ago
Clinical Trial Manager - Newark - Ardelyx
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.Position Summary:
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:
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.
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Clinical Trial Manager
Only for registered members Newark
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Clinical Trial Manager
Only for registered members Newark, California
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Senior Clinical Trial Manager
Only for registered members Newark
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Senior Clinical Trial Manager
Only for registered members Newark, CA
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Senior Clinical Trial Manager
Only for registered members Newark, California
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Clinical Trial Manager
Only for registered members Palo Alto
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Clinical Trial Manager
Only for registered members Palo Alto
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Clinical Trial Manager
Only for registered members Palo Alto
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Clinical Trial Manager
Only for registered members San Francisco Bay Area
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Clinical Trial Manager
Only for registered members Palo Alto, CA
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Clinical Trial Manager/Senior Clinical Trial Manager
Only for registered members Redwood City
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Clinical Trial Manager/Senior Clinical Trial Manager
Only for registered members Redwood City, CA
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Clinical Trial Manager
Only for registered members Redwood City
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Clinical Trial Manager
Freelance Only for registered members Redwood City
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Clinical Trial Manager
Full time Only for registered members Redwood City
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clinical trial manager
Full time Only for registered members Redwood City
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Clinical Trial Manager/Senior Clinical Trial Manager
Only for registered members Redwood City, CA
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Clinical Trial Manager
Only for registered members Redwood City, California, United States
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Clinical Trial Manager
Only for registered members Redwood City
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clinical trial manager
Only for registered members Redwood City, CA
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clinical trial manager
Only for registered members Redwood City, CA