About this role

Manage critical, trial and non-trial specific activities and functions that support the Clinical Data Management organization
Lead the development and oversight of administrative and trial and non-trial operations
Ensure regulatory compliance and effective collaboration with strategic partners
Define, implement, and oversee Quality Management (QM) within CDM
Manage the CDM documentation environment such as Standard Operating Procedures (SOPs)
Direct change management activities within CDM
Track, manage, and report on CDM KPIs, KQIs, and other metrics
Oversee the Ipsen CDM training environment

Approximately 5-7 years of experience in a CDM leadership position with proven Project Management skills in Data Management activities at a development program level
Ability to manage large projects: plan activities and tasks, identify project constraints and dependencies, identify and mitigate risks, report on project status, produce progress metrics, and communicate efficiently with external vendors as well as internal stakeholders
A good understanding of the drug development process
High knowledge of international standards (ICH, GCP, CDISC …) and regulations related to clinical studies and data management (preferred)
Technical expertise in CDM systems (preferred)
Formal change management experience or certification (preferred)

Director of Operations – Clinical Data Management

Key skills