Impact CTMS IT Support Avivys Consulting Services

4.0 - 9.0 years

9 - 19 Lacs

Hyderabad, Pune, Jaipur

Work from Office

IMPACT CTMS Support (IMPACT CTMS & Veeva Vault eTMF) Location: Remote Experience Required: 4-8 Years Domain: Life Sciences / Healthcare Notice Period: Immediate to 30 Days Job Summary The Clinical System Administrator (CSA) is responsible for the management, oversight, and maintenance of the Veeva Vault eTMF and Veeva Vault SafetyDocs systems, along with the IMPACT Clinical Trial Management System (CTMS). This role ensures all platforms remain compliant, operational, and support seamless clinical trial operations. The primary focus is on technical expertise in IMPACT CTMS, followed by Veeva Vault eTMF. Experience with Veeva Vault SafetyDocs is a strong advantage. CoreRequirements Mandatory: Proven IT/technical experience with IMPACT CTMS (e.g., Parexel CTMS, Calyx CTMS, Ennov CTMS), including system configuration, administration, and user support. Demonstrated experience in a support-based role, handling day-to-day tasks such as ticket resolution, troubleshooting, and end-user assistance. Preferred: Hands-on technical experience with Veeva Vault eTMF, particularly in system configuration, project setup, and workflow customization aligned with clinical operations. Nice to Have : Additional experience with Veeva Vault SafetyDocs is advantageous, particularly in supporting pharmacovigilance (PV) documentation and system administration. Key Responsibilities System Configuration & Management CTMS • - Define and manage standard study build configuration to support study operations. - Assist with custom study-specific configurations and timely setup of CTMS based on protocol and timelines. - Act as SME to support study workflows and configurations. System Configuration & Management eTMF and SafetyDocs •- Maintain default configurations to support clinical and PV documentation. - Timely and accurate project setup aligned with study timelines. - Act as SME to support study and PV program needs. - Support document transfer and archiving per regulatory standards. System Configuration & Management All Systems • - Assist with custom configurations, including security documentation. • - Ensure security compliance through audits and reviews . • - Manage system upgrades, patches, UAT testing, and release documentation. System Security - Define and manage application/project-level access and roles. • - Map roles to job functions and train users accordingly. - Monitor and review system security protocols and access controls. User Support & Training - Provide first-line technical support for CTMS, eTMF, and SafetyDocs. - Act as point-of-contact with vendors for escalations and outages. • - Develop and maintain training aligned with system releases and roles. • - Conduct bi-annual compliance checks for user training. Compliance & Documentation • - Ensure systems comply with GCP, ICH, 21 CFR Part 11, and Annex 11. • - Maintain complete documentation for configuration, validation, and SOPs. - Support audits and inspections ensuring systems are audit-ready. Data Integrity & Reporting - Oversee integration with systems (EDC, finance, etc.). - Resolve integration issues with IT and vendors as needed. System Improvement and Optimization - Identify and implement process improvements for efficiency. • - Collaborate with vendors to improve system performance. - Stay current with industry best practices. Desired Skills and Qualifications Education - Bachelor's degree in Life Sciences, Information Technology, or a related field (or equivalent experience). Experience - 2–4 years administering CTMS and/or eTMF/SafetyDocs systems in a CRO, pharmaceutical, or biotech environment. - Hands-on experience with leading platforms like IMPACT CTMS (Parexel/Calyx/Ennov), Veeva Vault, Medidata, Oracle Siebel CTMS. - Understanding of study operations, regulatory requirements, and tracking/reporting standards. Technical Skills - CTMS/eTMF administration, configuration, and reporting. - Familiarity with system integration across clinical platforms. - Troubleshooting and user support capabilities. - Basic SQL; experience with SSRS, Tableau, or Power BI is a plus. Soft Skills - Strong organization and multitasking abilities. - Effective communication and interpersonal skills. - Problem-solving mindset with process improvement focus. Preferred Qualifications - Prior CRO experience. - System validation and compliance audit exposure. - Veeva Certified Administrator (any module). - Familiarity with EDC, IVRS, and other safety databases

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