Clinical Data Manager

Integrated Resources Inc.; Lower Gwynedd Township (Montgomery County); On-site; USD 50,000 - 70,000; Full time

Job summary

A clinical trial management company is seeking a candidate to support study build activities and manage records in CTMS. Responsibilities include user administration, creating templates, and troubleshooting integration errors. A degree in a relevant field and experience with Clinical Trial Management systems are required.

Qualifications

• University/college degree is required.
• Preferred prior experience with Clinical Trial Management systems.
• Knowledge of the Clinical Trial Management process.

Responsibilities

• Work with Study Teams and create/maintain records in CTMS.
• Create/set up templates for various documentation.
• Assist with user administration and troubleshooting.

Skills

User administration

Troubleshoot integration errors

Report generation

Knowledge of Clinical Trial Management process

Education

University/college degree in health, computer science, business, engineering, or IT

Tools

Medidata CTMS

Siebel CTMS

Oracle SQL

Job description

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

PRINCIPAL 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
• 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
• 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:

• 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