Clinical Trial Manager

1 month ago

South San Francisco, California, United States Alumis Inc. Full time

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.

As a Clinical Trial Manager at Alumis, you will play a key role in supporting the Clinical Operations team across the full spectrum of study activities, including site activation, patient recruitment, study management, and site and vendor management for Phase I to Phase III trials. This role may involve leading Phase I clinical trials or supporting larger global studies as a site and/or vendor manager. You will collaborate cross-functionally within the Alumis team, as well as with study sites, CROs, and other vendors. Embracing our core values—We Elevate, We Challenge, We Nurture—you will contribute to the advancement of innovative treatments and improved patient outcomes.

Essential Responsibilities:

Support the overall operational execution of global 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.).
Manage the implementation, on-time execution, and conduct of clinical studies, contributing to and tracking the development of budget items, milestones, and timelines.
Oversee site feasibility and recruitment, including reviewing Site Information Questionnaires.
Manage assigned clinical documents (protocols, ICFs, and manuals) for clarity and accuracy, adhering to ICH/GCP guidelines.
Supervise assigned clinical study plans, including Clinical Monitoring, Communication, Project Management, and electronic Trial Master File (eTMF) Management.
Provide monitoring oversight through continuous review of CRO monitoring schedules, metrics, and monitoring visit reports [PSSV, SIV, IMV and COV]; conduct co-monitoring visits and audit of CRO processes.
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.
Independently manage vendor relationships and contribute to or lead the systems set-up/management, including EDC, IRT, Central Laboratories, and specialty services (ePRO, ECG, etc.).
Effectively 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.
Build and foster productive and collaborative relationships internally.

Professional Experience / Qualifications:
Demonstrated experience in applying US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards).
Strong written and verbal communication skills, with a proven ability to multitask.
Efficient time management and organizational skills.
Attention to detail and accuracy in work.

Preferred Education
B.S. or advanced degree in biological sciences or a related discipline.

Preferred Experience
A minimum of 5 years of relevant experience, ideally including work at a pharmaceutical or biotech company, or a Contract Research Organization (CRO).

Preferred Computer Skills
Proficiency in Microsoft Office (Word, Excel, Outlook), Smartsheet, electronic TMF, and electronic clinical technologies.
Alumis Values

Elevate
Challenge
Nurture

This position is located in South San Francisco, CA, with the expectation of being in the office 3 days a week, Tuesday through Thursday. At this time we are not considering remote applicants.
The salary range for this position is $ 150,000 USD to $165,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company's compensation practices.


Alumis Inc. is an equal opportunity employer.

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