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.
The Associate Director, Data Management (AD, DM) is responsible for ensuring high-quality management of clinical trial data in a rapidly evolving environment, in accordance with industry standards. This role oversees the execution of data management (DM) activities and deliverables across multiple studies, leading key initiatives such as Case Report Form (CRF) design, clinical database development, creation of Data Management Plans, external data transfer agreements, and CRF completion guidelines. Additionally, the AD, DM will ensure the implementation of programmed edit checks and data quality listings, track clean patient data, and oversee database closure. This position reports to the Senior Director, Data Management or a higher-level leader.
Responsibilities
- Serve as the DM Study Lead for one or more clinical trials.
- May provide line management for DM support roles.
- Represent Clinical Data Management (CDM) in cross-functional meetings.
- Ensure timely completion of DM project deliverables while maintaining quality standards and regulatory compliance from study start-up through study closure and archival.
- Establish and maintain strategic business relationships with CDM vendors; apply effective vendor management practices throughout the study.
- Ensure complete and accurate CDM documentation, including eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and Data Management Plans.
- Perform thorough development testing of eCRFs prior to deployment, including creating User Acceptance Test (UAT) Plans, Test Scripts, and executing testing as applicable.
- Ensure accurate development and execution of data integrations between EDC, IXRS, and/or external vendor data sources.
- Manage the setup and execution of data transfers for assigned studies, including the review of test data transfers for consistency with data transfer agreements.
- Participate in the Request for Proposal (RFP) process, including evaluating potential vendors.
- Review and contribute to study documents such as clinical study protocols, statistical analysis plans, and Mock Tables, Figures, and Listings (TFL) shells.
- Perform supplemental data reviews in alignment with data validation specifications and the Clinical Data Review Plan (CDRP).
- Participate in the review of blinded TFL outputs prior to final database locks.
- Report query trends and data/query/SDV metrics to the Study Execution Team (SET).
- Contribute to the development of EDC custom report specifications, SAS Clinical Programming report specifications, and associated outputs as needed.
- Prioritize projects and coordinate data management activities in support of corporate goals and objectives.
- Ensure DM project documentation is inspection-ready at all times.
- Lead or contribute to initiatives focused on DM process improvement, data quality assurance, and efficiency.
The Ideal Candidate
- 10+ years of relevant experience with a Bachelor’s degree or equivalent; MS or MBA preferred.
- Experience managing Phase I-IV clinical trials, both in-house and through CRO partnerships.
- Strong knowledge and experience with Electronic Data Capture (EDC) and other key technologies such as IXRS and data visualization tools.
- Proficiency in CDISC standards (CDASH, SDTM, ADaM).
- Experience with SAS, SQL, and/or other clinical programming tools.
- Strong understanding of clinical research regulations and guidelines, including FDA CFR and ICH GCP.
- Broad experience across all aspects of data management, including CRF and database development, data quality assurance and analytics, data transfer management, vendor oversight, study documentation, and inspection readiness.
- Strong knowledge of MedDRA and WHO Drug coding classification systems.
- Excellent interpersonal, organizational, and communication skills (oral and written).
- Proven ability to build strong relationships with internal and external stakeholders.
- Logical thinker with strong attention to detail, accuracy, and problem-solving abilities.
- Ability to prioritize tasks and adapt quickly to changing business conditions with a proactive, solutions-oriented approach.
- Willingness to travel as required.
Education
- Bachelor’s degree or equivalent in a relevant field, with a minimum of 10 years of experience in clinical data management.
- Master’s degree (MS or MBA) is a plus.
The salary range for this position is $195,000 USD to $220,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.
This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday.* At this time we are not considering remote applicants.
Alumis Inc. is an equal opportunity employer.
Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.
Other benefits include:
- Health insurance premiums paid at 90% for employee, 80% for dependents
- Free access to Genentech Bus & Ferry Share program
- $100 monthly cell phone stipend
- Unlimited PTO for Exempt employees
- Free onsite gym and a kitchen stocked with yummy snacks and drinks!
We are a hard-working, collaborative team on a mission to transform patient’s lives-- and we aspire to elevate, challenge and nurture one another along the way.
Top Skills
What We Do
At Alumis, our goal is to significantly improve the lives of patients by replacing broad immunosuppression with targeted therapies.
We recognize that patients living with immune-mediated diseases need alternatives to currently available therapies. Despite recent advances and innovations in the treatment of immune-mediated diseases, many patients continue to suffer, cycling through currently approved therapies while looking for a solution that alleviates the debilitating impact of their disease without life-limiting side effects.
Addressing the needs of these patients is why we exist. We are pioneering a precision approach that leverages insights we derive from powerful data analytics to select the right target, right molecule, right indication, right patient, and right endpoint resulting in optimized outcomes for patients. We believe that combining our insights with an integrated approach to drug development will produce the next generation of treatments to address immune dysfunction.
Incubated by Foresite Labs, Alumis is led by a team of deeply experienced professionals who are devoted to transforming the lives of patients with immune-mediated diseases by developing a pipeline of transformative therapies.
