About the job
Alumis Inc. is at the forefront of precision medicine, dedicated to revolutionizing the treatment landscape for patients suffering from autoimmune diseases. Despite recent advancements in treatment, many individuals with immunologic conditions still face significant challenges. Our mission is to fundamentally improve their health outcomes through innovative therapeutic solutions.
The Clinical Data Management (CDM) Contractor plays a crucial role in the meticulous management of clinical trial data within a fast-paced environment, adhering to industry standards. This position involves supporting and potentially leading data management activities and deliverables across one or multiple clinical studies.
Key Responsibilities:
- Act as the Data Management Study Lead or provide support for various studies.
- Represent Data Management in cross-functional meetings as necessary.
- Ensure timely completion of Data Management project deliverables in line with quality standards and regulatory requirements from study initiation to closure/archival.
- Effectively manage vendors throughout the study process.
- Oversee the creation and accuracy of essential Data Management documentation, including eCRF specifications, completion guidelines, annotated CRFs, validation specifications, transfer agreements, and management plans.
- Conduct comprehensive testing of the eCRF prior to its deployment, including the development of User Acceptance Testing (UAT) plans and scripts.
- Ensure the accurate development and execution of data integrations among EDC, IXRS, and/or external vendor data sources.
- Manage and oversee data transfers for assigned studies, including reviewing test data for consistency with transfer agreements.
- Participate in the review of study documents such as clinical study protocols and statistical analysis plans.
- Conduct data quality checks as outlined in the validation specifications or Clinical Data Review Plan (CDRP).
- Review blinded TFL output prior to final database locks.
- Report query trends and metrics to the Study Execution Team (SET).
- Contribute to the development of custom report specifications as needed.
- Maintain DM project documentation in a state ready for inspection.
