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Assoc Clin DB Validation Mgr
full-timeKochi, Bengaluru

Summary

Location

Kochi, Bengaluru

Type

full-time

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About this role

Job Overview
Manage end-to-end delivery of testing services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive testing expertise to testing team to provide high quality database that meet customer requirements. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

Essential Functions
• 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 strong 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 process; 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 strong Customer relationships.
• All responsibilities are essential job functions unless noted as nonessential (N).

Qualifications
• Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology  Req
• 4- 6 years of relevant clinical DB Testing experience in CDMS Platforms and total exp being 6+ yrs Req

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

Other facts

Tech stack
Project Management,Testing,Database Management,Quality Assurance,Communication,Leadership,Regulatory Compliance,Risk Management,Training,Mentoring,Financial Management,Customer Relationship Management,Process Improvement,Documentation,Team Coordination,Technical Expertise

About IQVIA

IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI™, advanced analytics, the latest technologies and extensive domain expertise. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific progress, in an effort to advance healthcare. To learn more, visit www.iqvia.com.

Team size: 10,001+ employees
LinkedIn: Visit
Industry: Hospitals and Health Care

What you'll do

  • Manage end-to-end delivery of testing services for projects, ensuring quality deliverables on time and within budget. Provide leadership and expertise to the testing team while complying with Good Clinical Practices and regulatory guidelines.

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Frequently Asked Questions

What does a Assoc Clin DB Validation Mgr do at IQVIA?

As a Assoc Clin DB Validation Mgr at IQVIA, you will: manage end-to-end delivery of testing services for projects, ensuring quality deliverables on time and within budget. Provide leadership and expertise to the testing team while complying with Good Clinical Practices and regulatory guidelines..

Why join IQVIA as a Assoc Clin DB Validation Mgr?

IQVIA is a leading Hospitals and Health Care company.

Is the Assoc Clin DB Validation Mgr position at IQVIA remote?

The Assoc Clin DB Validation Mgr position at IQVIA is based in Kochi, Kerala, India and Bengaluru, India. Contact the company through Clera for specific work arrangement details.

How do I apply for the Assoc Clin DB Validation Mgr position at IQVIA?

You can apply for the Assoc Clin DB Validation Mgr position at IQVIA directly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process. You can also learn more about IQVIA on their website.