Clinical Data Manager

Job Description
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).

Qualifications
EDUCATION AND EXPERIENCE REQUIREMENTS:
• Include any degrees or certifications which are required and/or desirable.
• University/college degree is required; preferred in health, computer science, business, engineering, or information technology
• Preferred prior experience with Medidata CTMS and/or Siebel CTMS or other Clinical Trial Management systems.
• Knowledge of the Clinical Trial Management process
• Oracle SQL experience is preferred but not required
• 3 - 5 years of professional experience.

Additional Information
Kind Regards,
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
DIRECT # - 732-662-7964