Clinical Data Manager

PRINCIPAL RESPONSIBILITIES:

List most complex or difficult parts of job first. Describe scope of responsibilities.

• Work with Study Teams and partners during study build process to create/maintain the following in CTMS:

• Study, Country, Site, Contacts, and Institution records

• Create and set up templates such as Health Authority, IRB/IEC, Financial Disclosure, Subject Visit, Visit/Trip Report, etc.

• Update system dropdown values

• Create/Update assignments, configurations, properties, attributes, triggers, and parameters in the system.

• User administration

• Import/Export templates

• Add Payees and study triggers

• Visit Schedules

• Subject deviations/central findings

• Any other general study build activities

• Troubleshoot integration errors between CTMS and other applications

• Provide Study build activities for Grants Manager

• Create study

• Upload templates

• Create/Add sites

• User administration (send invitations)

• Any other general study build activities

• Assist with UAT activities

• Provide general business support for CTMS and Grants Manager applications

• Create/Generate reports

• Run SQL queries

• Support Ticket generation/creation and maintenance (tracking of issues/requests)

• Create/Update reference and training materials/documentation

PRINCIPAL RELATIONSHIPS:

Reports to Manager, Clinical Trial Management Business Support

Internal interfaces: Study Teams, Champions, Transition Agents, Other support team members, IT.

External interfaces: External vendors as necessary (e.g., flexible resource, Medidata vendor).