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Iqvia Biotech
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Assoc Clin DB Validation Mgr

Assoc Clin DB Validation Mgr

Iqvia Biotech

1 - 4 years

6 - 10 Lacs

kochi

Posted:1 day ago| Platform:

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Skills Required

oracle c software testing data validation manual testing dbms sql server sql ds jcl java cobol biosimilars cics hp alm html db vsam unix communication skills jira

Work Mode

Work from Office

Job Type

Full Time

Job Description

Manage end-to-end delivery of testing services for single/multi-service projects, ensuring quality deliverables on time and within budget.
Provide comprehensive testing expertise to the testing team to create high-quality databases that meet customer requirements.
Lead the team in project planning, execution, and close-out, including financial management, communications, and milestone deliverables.
Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and CDM guidance documents.
Attend Kick Off Meetings and regular project meetings until Study Go Live.
Take full responsibility for creating Edit Checks Test Plan documents and writing test cases.
Release the Edit Checks Test Plan to the testing team for testing activities.
Review Project Plans and escalate issues to all stakeholders.
Understand study protocols and share basic requirements with validation project teams.
Perform eCRF and Time & Events QC according to the QC checklist.
Test email alerts.
Review ASB and Edit Specification documents, provide input, and escalate issues if any.
Document changes made to Edit Specifications within the Test Plan during validation in version history.
Request final and authorized versions of documents to validate system configuration (AUL, Rights and Roles, Home page, System Settings).
Provide project status updates on validation activities to Data Team Lead/Lead Programmers.
Review Testing Comments Log after each cycle of testing and provide it to Programmer.
Document all testing documentation in eDMSF in a timely manner.
Coordinate regularly with internal customers and establish strong communication with them.
Work with functional managers to ensure appropriate resources are assigned to meet project deliverables.
Implement proactive quality management plans across multiple projects/programs.
Track service performance and lead efforts to identify root causes of issues and implement remedial actions.
Continuously seek opportunities to improve processes; work with the team to develop and implement plans to reorganize and drive change across multiple projects/programs (with minimal support).
Ensure timely follow-up and resolution of compliance issues.
Serve as a Subject Matter Expert (SME) for the validation group.
Train and mentor Testing Team Members.
Manage end-to-end project management for testing activities, including resource planning, deliverable planning, risk identification, and escalation.
Conduct Quality Reviews as applicable.
Review QIP for budget allocation and communicate out-of-scope activities.
Review individual project financial performance and communicate issues to stakeholders.
Adhere to study budgets.
Supervise new technology implementation.
Serve as the primary point of contact for Internal Customers on testing deliverables.
Justify and negotiate directly with Internal Customers regarding timelines, financial aspects, process improvements, and resource allocation.
Develop and maintain strong Customer relationships.

Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

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Iqvia Biotech

Pharmaceuticals / Biotechnology

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