Assoc Clin DB Validation Mgr at IQVIA

Kochi, Kerala, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalIndustries

Requirements

Bachelor's Degree in Science/Computer Science/Information Technology or Bachelor in Technology (Req)
4-6 years of relevant clinical DB Testing experience in CDMS Platforms (Req)
Total experience of 6+ years (Req)

Responsibilities

Manage end-to-end delivery of testing services for single/multi-service projects, ensuring quality deliverables on time, within budget, and to customer satisfaction
Provide comprehensive testing expertise to the testing team to deliver high-quality databases meeting customer requirements
Provide leadership and vision to the team in project planning, execution, close-out, financial management, communications, and milestone deliverables
Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and 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 to all stakeholders
Comprehend study protocol and share basic protocol requirements 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 changes to Edit Specifications in version history 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 to Programmer
Document all testing documentation in eDMSF in a timely manner
Coordinate with internal Customers regularly and establish strong communications
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, provide leadership to identify root causes of issues, and implement remedial actions
Continuously look for process improvement opportunities, develop and implement plans to reorganize and drive change across multiple projects/programmes (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, including proactive resource planning, planning for deliverables, identifying risks, and escalating to Manager
Conduct Quality Reviews as applicable
Review the QIP for appropriate budget allocation and communicate out-of-scope activities
Review individual project financial performance and communicate issues to 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

Skills

Key technologies and capabilities for this role

Edit Checks Test PlanTest Case WritingeCRF QCTime & Events QCEmail Alerts TestingASB ReviewEdit SpecificationsGCP ComplianceSOPsProject PlanningTesting DocumentationeDMSFClinical Database Validation

Questions & Answers

Common questions about this position

What are the main responsibilities of this role?

The role involves managing end-to-end delivery of testing services for projects, ensuring quality deliverables on time and within budget, providing testing expertise, leadership in project planning and execution, and complying with GCPs, regulatory guidelines, SOPs, and CDM documents.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this position?

This information is not specified in the job description.

What leadership and team responsibilities does this role include?

The role requires providing leadership and vision to the team, training and mentoring testing team members, working with functional managers for resource assignment, and serving as a Subject Matter Expert for the validation group.

What experience makes a strong candidate for this position?

Strong candidates will have expertise in clinical database validation, project management for testing activities, knowledge of GCPs and regulatory guidelines, experience creating test plans and cases, and skills in mentoring teams and managing multiple projects.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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