Head of Clinical Data Management

Our culture is entrepreneurial, inclusive and caring. We're passionate about our work. And we embrace a pioneering spirit. Join us as we strive to develop innovative therapies with the power to give people with genetic diseases freedom for life.

Job Summary

As a senior role within Clinical Development Operations, the Head of Clinical Data Management, will be accountable for the delivery, integrity, and quality of the clinical data across AVROBIO’s portfolio. S/He will be responsible for building a high-functioning data management team and serve as the in-house data management expert. S/He will develop a clear operational roadmap for the Clinical Development Management function, including but not limited to developing data standards (CDISC programming, TFLs, SDTM, and ADaM datasets), eCRF libraries, and standard procedures to support data transfers and agreements, interim data cuts/analyses, and database locks; creating data management reports and metrics; and ensuring data system compliance. Additionally, s/he have strategic responsibility for oversight of Contract Research Organization (CRO) activities related to data management, including project management, vendor management, and coordination of internal reviews. 

This is a critical role for AVROBIO to ensure data quality and integrity. 

Research and Development
Key Responsibilities
  • Reviews performance metrics and trends for DM deliverables on assigned studies/programs and ensures optimal execution
  • Lead the development and adaptation of new data management platforms
  • Accountable for overall consistency of DM standards across assigned trials/program and quality/integrity of the data.
  • Create standard CRF library components as well as Implementation of CDISC data standards across multiple clinical studies (CDASH, SDTM, ADaM)
  • Supports special projects and initiatives; partners with Statistical Programming, Biostatistics, Vendor Management, and Quality as well as Global Development depending on type of project.
  • Line Management of data managers ensuring quality standards across programs and studies
Minimum Requirements/ Qualifications
  • 10+ years clinical data management leadership within Bio/Pharma
  • Deep understanding of drug development and biopharmaceutical industry required
  • Demonstrated ability to communicate and write clearly, concisely, and effectively
  • High attention to detail including proven ability to manage multiple, competing priorities
  • Strong analytical skills and ability to interpret and present complex data clearly
  • Independently motivated, and good problem-solving ability
  • Aptitude for compilation, analysis, and presentation of data
  • Ability to work successfully within a cross-functional team and a matrix organization
  • Knowledge of current regulatory requirements and guidelines governing clinical research

AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

AVROBIO, Inc is an EEO employer