• US Citizen

• Green Card

• EAD (OPT/CPT/GC/H4)

• H1B Work Permit

• Corp-Corp

• W2-Permanent

• W2-Contract

• Contract to Hire

• Consulting/Contract

• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 16th Jan 2024

Summary: CTMS Business Support is responsible for supporting systems/processes for any system supported by Clinical Trials Management Solutions team and mainly includes study build activities in Clinical Trial Management System (CTMS), troubleshoot issues, ensure high quality data and smooth integration between CTMS and other systems.

Qualifications:

• 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 databas

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

o 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