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 CTM you will work closely with the Clinical Operations team to support the full scope of study activities, including site activation, patient recruitment, study monitoring, and site and vendor management on Phase 3 trials. This role may focus on leading a Phase 3 clinical trial or supporting larger global studies as a site and vendor manager. You will work cross-functionally within the Alumis team as well as with study sites, CROs, and other vendors.
- Support 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 and tracking the development of budget items, milestones, and timelines, in addition to contributing to the scope and management of resources (including vendor selection), leading to overall quality, safety, and compliance throughout the duration of the clinical studies and program.
- Responsible for site feasibility and recruitment, including review of Site Information Questionnaires.
- Responsible for assigned clinical documents (i.e. protocols, ICFs, and manuals) for clarity and accuracy and following ICH/GCP guidelines.
- Responsible for assigned clinical study plans, including Clinical Monitoring, Communication, Project Management, and electronic Trial Master File (eTMF) Management.
- Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished.
- Participates in assigned activities related to user acceptance testing (UAT) of clinical systems, including EDC and interactive response technology (IRT), and may contribute to the authoring of systems requirements.
- Responsible for vendor management as well as contributing to or leading the systems set-up/management including EDC, IWRS, Central Laboratories, and specialty services (ePRO, ECG, etc.).
- Effectively tracks and communicates program/study progress to Study Lead and Senior Management with the ability to create and update detailed dashboards and trackers.
- Represent the department in a professional manner; build and establish good relationships with investigators and all other study personnel.
- Build productive and collaborative relationships internally.
Education and/or experience:
- Bachelor’s degree, preferably in areas such as biological sciences, health care management, or life sciences research; BSN/RN or experience with management of clinical trials.
- Typically requires a minimum of 5 years of related experience.
- Previous employment at a pharmaceutical or biotech company is required.
- Highly proficient using the Microsoft Office Suite (i.e., Word, Excel, PowerPoint, Adobe).
- Knowledge in additional applications.
- Demonstrated experience in the application of US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards).
- Good written and verbal communication skills and proven ability to multitask. Efficient time management and organizational skills. Attention to detail and accuracy in work.
B.A. or advanced degree in biological science or life sciences discipline.
Certifications a plus ex. Project Management Professional, Clinical Trials Design and Management, etc.
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Alumis Inc. is an equal opportunity employer.
If you are hired, we will require you to prove that you have received the primary series of an FDA-approved or authorized COVID-19 vaccine and at least one booster or have a valid religious or medical reason not to be vaccinated.