Associate Director, Data Management
Location: South San Francisco
Posted on: June 23, 2025
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Job Description:
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.
Keywords: , Santa Clara , Associate Director, Data Management, Science, Research & Development , South San Francisco, California
