CO PM with CTMS & eTMF experience CBCC Global Research

6.0 - 10.0 years

10 - 18 Lacs

Ahmedabad

Work from Office

Dear Candidate, We are looking for someone with 68 years of experience in CRA, CTL, or CM roles for this position. This is an office-based job, and the location will be Ahmedabad. Working Days: Monday to Friday (Weekends off) Working Hours: 9 hours per day (Flexible timing) Role & responsibilities Responsible for end-to-end validation of CTMS and eTMF systems including system implementation, configuration change requests, periodic upgrades, Integration points with other systems (e.g., EDC) to improve the efficiency Perform periodic review and re-validation in accordance with system SOPs and sponsor-specific requirements. Conduct regular training sessions and refreshers on CTMS/eTMF systems for new hires and project teams. Provide the demo training of CTMS/eTMF systems to sponsor and internal stakeholders as applicable Responsible for user management onboarding, access provisioning, and periodic access review. Maintain access form for application user access and project specific access Develop and maintain study templates and configuration guides to standardize CTMS/eTMF use across projects. Maintain system-specific SOPs, work instructions, and validation documentation templates. Maintain and provide a support for user queries and issues. Liaise with vendor support and track resolutions for system bugs, performance issues, and configuration changes. Identify recurring operational inefficiencies and propose workflow improvements in CTMS and eTMF usage. Work with IT or software developer teams to develop auto-alerts/reminders, customize dashboards for operational oversight, data import/export but not limited too. Support vendor qualification processes for new CTMS/eTMF platforms or major upgrades as applicable. Monitor audit trail and metadata integrity within eTMF and CTMS. Ensure business continuity plans for system downtime, data recovery, and backup. Preferred candidate profile

Posted 1 month ago

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