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.