Senior Director, Clinical Data Management

California. Posted a month ago

The role

You will define and execute the global clinical data management strategy and build a high-performing team. You will manage full-lifecycle clinical data quality and oversee CROs and specialty vendors.

What you will do

Building and scaling a high-performing Clinical Data Management team
Planning and managing full-lifecycle clinical data quality and integrity across all trials
Driving compliance with global regulatory standards and internal SOPs
Cultivating strong cross-functional partnerships
Leading the selection, oversight, and performance management of CROs and specialty vendors
Managing vendor budgets
Serving as the primary escalation point for clinical data management issues

Required qualifications

Advanced degree (Master’s) in Life Sciences, Statistics, Data Science, or a related quantitative field
At least 10 years of industry experience
At least 5 years as a people manager
Expertise in building and leading clinical data management teams
Experience in resourcing global registrational studies
Deep experience leading end-to-end data management for clinical trials
Experience with database design/build/UAT, edit checks/validation, review/reconciliation, and database lock
Experience with the design, validation, and maintenance of DM deliverables using relevant Clinical Data Manager platforms and enabling technologies
Deep understanding of data structures and integrations across EDC and connected systems
Comprehensive knowledge of the clinical development lifecycle, data flow, and cross-functional dependencies
Advanced proficiency in CDISC standards (CDASH, SDTM, Define-XML), metadata management, and controlled terminologies
Working knowledge of SOPs, ICH-GCP, 21 CFR Part 11/Annex 11, and privacy expectations

Benefits

Equity
Annual bonus dependent on individual and company performance
6% 401K contribution
USD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits

Before you apply

Please submit your application through our website and refer to Job ID 23418 in your cover letter
We are only able to contact those who are selected for an interview

About the company

AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology.