The Clinical Data Manager will have a demonstrated ability to oversee the data management activities across a single clinical program or group of related studies.
Provides Data Management leadership and expertise to project and study teams.
Will have an good knowledge of the end to end clinical research and data management processes, as well as global regulatory and industry rules and guidances (i.e. ICH, GCP) to support drug development processes and global project submissions through to approval.
Responsible for managing data management components of project and study budgets and vendor performance.
May mentor team members and more junior staff and may direct activities of contract Data Manager staff .
Takes leadership role in project implementation as a member of the clinical study or project team, ensures oversight of the Data Management CRO ; provides status reports/updates, resolves disputes, and ensures timely acquisition of high quality deliverables from the CRO.
Provides Data Management expertise to the team in identifying opportunities for process and budgetary optimization Coordinates with Biostatistics and Statistical Programming to ensure appropriate design, documentation, testing and implementation of SAS data deliverables according to internal and regulatory standards.
Works with team members via matrix relationships (internally or at CROs) by directing work, resolving problems and/or providing guidance
B.S. degree in Scientific or related field is preferred.
Minimum of 5-7 years as a Senior Data Manager within a Data Management organization
Experience with leading teams and/or organizations.