IQVIA
life sciences and healthcare
AssocClinDBValidationMgr
“Assoc Clin DB Validation Mgr at IQVIA. Skills: end-to-end delivery of testing services, testing expertise, leadership and vision, project management, quality management, customer relationship management. Manage end-to-end delivery of testing services for single/multi-service projects. Provide comprehensive testing expertise to testing team”
What You'll Achieve.
ensuring quality deliverables on time and within budget, to customer satisfaction; meet customer requirements; Ensure adherence to study budgets
Industry & Context.
identify root cause of issues and implement remedial actions; risk identification
What They're Looking For.
Must Have
Bachelor in Science/Computer science/Information Technology or Bachelor in Technology, 4-6 years of relevant clinical DB Testing experience in CDMS Platforms, total exp being 6+ yrs
What You'll Do.
Manage end-to-end delivery of testing services for single/multi-service projects, Provide comprehensive testing expertise to testing team, Provide leadership and vision to the team in the areas of project planning, execution, and close-out
financial communications
and milestone deliverables, Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents, Attend Kick Off Meeting and regular project meetings until Study Go Live, Take complete responsibility for creation of Edit Checks Test Plan document and writing test cases, Release the Edit Checks Test Plan to the testing team to conduct testing activities, Review Project Plan and escalate issues (if any) to all stakeholders, Comprehend study protocol and share the basic requirement of protocol with validation project team, Perform eCRF and Time & Events QC as per QC checklist, Test email alerts, Review ASB and Edit Specification document, provide input and escalate issues if any, Document in version history if any changes made to Edit Specifications within Test Plan during validation process, Request final and authorized version 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 Testing Comments Log to Programmer, Document all testing documentation in eDMSF in a timely manner, Co-ordinate with internal Customers on a regular basis and establish Communications with them, Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables, Implement proactive quality management plans across multiple projects/programmes, Track service performance and provide leadership to identify root cause of issues and implement remedial actions, Continuously look for opportunities to improve the work with team to develop and implement plan to re-organize and drive change across multiple projects/programme (with minimal support), Ensure timely follow-up and resolution of compliance issues, Serve as Subject Matter Expert (SME) for validation group, Train and mentor Testing Team Members, Provide end to end Project Management for testing activities in the team, e. g. proactive and accurate resource planning, planning for deliverables, identifying risks (if any) and escalate such risks to the Manager, Conduct Quality Reviews as applicable, Review the QIP for appropriate budget allocation and communicate if any out of scope activities are noted, Review individual project financial performance and communicate issues to the appropriate stakeholders, Ensure adherence to study budgets, Supervise implementation of new technology, Serve as primary point of contact for Internal Customers on testing deliverables, Provide justification for and perform direct negotiations with Internal Customers, e. g. , timelines, financial, process, resources, Develop and maintain Customer relationships
How You'll Work.
Team & Collaboration
Provide leadership and vision to the team; Release the Edit Checks Test Plan to the testing team; escalate issues (if any) to all stakeholders; share the basic requirement of protocol with validation project team; Provide project status updates on validation activities to Data Team Lead/Lead Programmers; Co-ordinate with internal Customers on a regular basis and establish Communications with them; Work with functional manager(s) to ensure appropriate resources are assigned; Work with team to develop and implement plan to re-organize and drive change; Train and mentor Testing Team Members; escalate such risks to the Manager; Serve as primary point of contact for Internal Customers on testing deliverables; perform direct negotiations with Internal Customers
Communication Scope
financial communications; Provide project status updates; Co-ordinate with internal Customers on a regular basis and establish Communications with them; communicate if any out of scope activities are noted; communicate issues to the appropriate stakeholders; Serve as primary point of contact for Internal Customers; perform direct negotiations with Internal Customers
Process & Methodology
end-to-end delivery of testing services, project planning, execution, close-out, milestone deliverables, Review Project Plan, resource planning, planning for deliverables, risk identification, Quality Reviews, budget allocation review, financial performance review, adherence to study budgets, negotiations
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