Data Management Contractor
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 Data Management (DM) Contractor will be responsible for ensuring high-quality management of clinical trial data in a rapidly evolving environment, in accordance with industry standards. The DM Contractor will support and/or lead DM activities and deliverables across one or multiple studies.
Essential Responsibilities:
- May serve as DM Study Lead or DM support for one or more studies
- Represent DM in cross-functional meetings as applicable
- Ensure DM project deliverables are completed on time and in accordance with quality standards and regulatory requirements from study start-up through study closure/archival
- Apply effective vendor management throughout the study
- Responsible for ensuring complete and accurate DM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements and data management plans
- Perform thorough development testing of the eCRF prior to deployment, inclusive of 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
- Responsible for setup and management of data transfers for assigned studies, including review of test data transfers for consistency with data transfer agreements
- Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells
- Perform supplemental data reviews according to the data quality checks outlined in the data validation specifications or Clinical Data Review Plan (CDRP)
- Participate in reviews of blinded TFL output prior to final database locks
- Report query trends and data/query/SDV metrics to the Study Execution Team (SET)
- Participate in the development of EDC custom report specifications, SAS Clinical Programming report specifications and/or associated outputs as needed
- Ensure DM project documentation is in an inspection-ready state
Qualifications:
- 10+ years of relevant experience and has earned a BS or equivalent degree; MS or MBA a plus
- Experience running Ph I-IV clinical trials, both in-house and through CRO partners
- Strong knowledge and experience in EDC and other key technologies (e.g., IXRS, data visualization)
- Proficiency in CDISC standards (CDASH, SDTM, ADaM)
- Experience with SAS, SQL and/or other clinical programming tools
- Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP
- Depth of experience across all aspects of DM, including but not limited to: CRF and database development, data quality assurance and analytics, data transfer management, vendor management, DM study documentation and inspection readiness.
- Strong understanding of the application of MedDRA and WHO Drug clinical data coding classification systems
- Strong interpersonal, organizational, and communication (oral and written) skills
- Demonstrated ability to cultivate strong working relationships with internal and external colleagues.
- Logical thinking, attention to detail and accuracy, strong organizational skills, and problem-solving abilities
- Ability to prioritize and to adapt quickly to changing business conditions with a “can-do” attitude
- Capable of proactively identifying project challenges and risks and proposing appropriate and strategic solutions to issues.
Alumis Values
• We Elevate
• We Challenge
• We Nurture
This position is located in South San Francisco, CA and contractors are expected to be onsite Tuesday-Thursday. Open to remote applicants with requirement to be onsite 1-2x a quarter.