Associate Director, Standards and Systems, Clinical Data Management

The Role

The Associate Director, Standards and Systems is operationally responsible for the development, maintenance and adherence to Genmab’s clinical data standards including eCRFs, edit checks, electronic case report forms (eCRFs) Completion Guidelines, controlled terminology, CDISC, CDASH and etc.  The Associate Director provides leadership for the continued development and enforcement of data standards through extensive collaboration with Data Management, Clinical Programming, Medical, Stats and other cross-functional teams where needed. The Associate Director works to implement data standards after an extensive upstream/downstream impact is assessed, maintaining consistency with related supportive processes to ensure accurate and seamless use of end-to-end Genmab standards.

Summary

The Associate Director, Standards and Systems has expertise in the development of eCRFs for complex oncology clinical trials and Industry...