Alumis Inc. logoAlumis Inc. logo

Clinical Data Management Contractor

Alumis Inc.South San Francisco
On-site Contract

Clicking Apply Now takes you to AutoApply where you can tailor your resume and apply.


Experience Level

Mid to Senior

Qualifications

Qualifications:Minimum of 10 years of relevant experience, holding a BS or equivalent degree; MS or MBA is advantageous. Proven experience managing Phase I-IV clinical trials, including both in-house and outsourced environments. Strong understanding of data management processes and regulatory compliance. Excellent communication and interpersonal skills for cross-functional collaboration. Ability to adapt to a rapidly changing environment and manage multiple priorities effectively.

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.

About Alumis Inc.

Alumis Inc. is a pioneering precision medicines company committed to transforming the lives of patients with autoimmune diseases through innovative solutions and a steadfast dedication to improving treatment outcomes.

Similar jobs

Browse all companies, explore by city & role, or SEO search pages.

Tailoring 0 resumes

We'll move completed jobs to Ready to Apply automatically.