JOB POSTING

Manager / Senior Manager, Clinical Data Management

ALX Oncology Inc. is a publicly-traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, ALX148, is a next-generation CD47-blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. Our new company headquarters are located in South San Francisco, California.

Reporting to the Head of Biometrics, we are seeking an exceptionally talented individual to provide data management expertise for the Company‚Äôs lead program, ALX148. The Manager / Senior Manager, Clinical Data Management will work in an outsourced data management model, and manage and perform the end-to-end clinical data management activities for their assigned clinical program, while ensuring the highest level of data quality and compliance. This position will be an individual contributor role that will lead data management activities. This individual will interface with the project team to ensure that data management services are delivered in a consistent, high-quality manner, and will provide input into Biometrics strategy and implement department initiatives. This individual will also independently perform/oversee tasks related to database and report setup, as well as processing and cleaning clinical trial data, following all applicable standard and study-specific procedures. Work will be performed remotely during the pandemic, but this position will be expected to move in-house in South San Francisco, CA, when conditions permit.

Key Responsibilities

  • Serve as a data management expert and be the CDM lead for assigned clinical studies on multidisciplinary project teams.
  • Deliver high quality data for analysis and study milestones.
  • Review protocols from a CDM perspective and provide functional-expert feedback.
  • Review and approve key clinical data management deliverables, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, serious adverse event reconciliation plans, medical coding, data listing specifications, and electronic data transfer agreements.
  • Manage/oversee study setup, testing and system validation for new studies in partnership with the DM vendor.
  • Oversee data cleaning activities executed by the CRO and ensures protocol-specified guidelines are applied to the review and cleaning of clinical data.
  • Collaborate with internal Biostatistics, Medical Monitors and Clinical Operations on identifying critical variables in the clinical dataset, for protocol-specified endpoints. Coordinate implementing these variables into CRO DM activities.
  • Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management CRO and ALX project team.
  • Monitor vendor performance to ensure timelines and data quality standards are met.
  • Ensure compliance of clinical data management processes with applicable regulations and guidelines.
  • Help identify and support solutions to manage complex issues and escalate to senior management as appropriate.
  • Perform work and process redesign to improve individual and team effectiveness.
  • Ensure deadlines are met and inform key stakeholders of project/program status.
  • Promote constructive, effective relations with and between team members.
  • Travel may be required (up to 5%).

Education and Experience

  • BA/BS or higher preferably in math, science or health-related field with a minimum of 6 years of experience in clinical data management across phase 1- 3 clinical trials. At least 5 years of the overall experience require acting as a study lead data manager.
  • Experience in regulatory GCP inspections/audits is a plus.
  • Comprehensive experience working with clinical database systems.
  • Working knowledge of CDISC including CDASH, TAUG and SDTM as well as data privacy regulations e.g. GDPR.
  • Successfully manage clinical data management vendors, contractors and service providers for program deliverables.
  • Experience in Oncology and/or Immuno-oncology trials preferred.
  • Able to work in a fast paced and dynamic environment while effectively managing multiple projects which may have changing priorities.
  • Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors.
  • Excellent verbal and written communication skills and interpersonal skills.
  • Strong analytical and problem-solving skills.

To apply for this position, please send your cover letter and resume to hr@alxoncology.com