Clinical Trial Manager

1 week ago

South San Francisco, California, United States Alumis Inc Full time
Join Alumis Inc. as a Clinical Trial Manager

Alumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. 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.

Key Responsibilities:
  • Support the overall operational execution of global clinical studies on one or more clinical programs from initial study synopsis through final project deliverables.
  • 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.
  • 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.
Requirements:
  • 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 Qualifications:
  • B.S. or advanced degree in biological sciences or a related discipline.
  • A minimum of 5 years of relevant experience, ideally including work at a pharmaceutical or biotech company, or a Contract Research Organization (CRO).
  • 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 vary based on the Company's compensation practices.

Alumis Inc. is an equal opportunity employer.

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