CTMS Business Support Analyst
Job Description
Role- CTMS Business Support Analyst
Location – Titusville, NJ or Wayne, PA (Hybrid)
Mode- Contract (W2)
Candidate should have strong experience on CTMS (Clinical Trial Management Systems)
Job Description ::
Prior experience with Clinical Trial Management Systems (CTMS) such as Medidata, Siebel, Veeva Vault or any other
3-5 years of professional experience
Knowledge of the Clinical Trial Management process
Proficient in using MS Office Suite of applications
Should have strong problem-solving skills and good communication skills
Able to run SQL queries from Oracle or other SQL-based database
Responsibilities:
• Work with Study Teams and partners during study build process to create/maintain the following in CTMS:
o Study, Country, Site, Contacts, and Institution records
o Create and set up templates such as Health Authority, IRB/IEC, Financial Disclosure, Subject Visit, Visit/Trip Report
o Update system dropdown values
o Create/Update assignments, configurations, properties, attributes, triggers, and parameters in the system
o User administration
o Import/Export templates
o Add Payees and study triggers
Visit Schedules
o Subject deviations/central findings
o Any other general study build activities
o Troubleshoot integration errors between CTMS and other applications
• Assist in analyzing large data sets
• Assist with UAT activities
• Provide general business support for CTMS, and other applications supported by the Clinical Trial Management Solutions team
• Create/generate reports
• Run SQL queries
• Support ticket generation/creation and maintenance (tracking of issues/requests)
• Create/update reference and training materials/documentation
• Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document
• Primary interfaces: Reports to AD, Manager, or Lead of Clinical Trial Management Business Support, Study Teams, Champions, Transition Agents, Other support team members, IT
• Other Interfaces: External vendors as necessary (e.g. Medidata vendor)
• Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements