Clinical Data Specialist

Job Overview

Essential Functions

Provide expertise in validation tasks and perform database validation activities to ensure delivery of high-quality clinical databases.

Lead database audit activities and oversee validation efforts across assigned studies.

Take accountability for the overall quality, accuracy, and timely delivery of database validation activities.

Test clinical trial databases and review/edit database specifications as required.

Create, document, and maintain test cases within the Data Management Plan (DMP).

Reconcile Edit Check status prefixes using DMP reconciliation reports.

Update Edit Check statuses within the Data Management Plan and Clinical Trial Database (CTDB) as applicable.

Identify and communicate erroneous Edit Checks to database programmers for correction.

Escalate document updates, discrepancies, and uncertainties to the Lead Data Manager.

Ensure compliance with all core operating procedures, quality standards, and work instructions.

Establish and maintain strong working relationships with Clinical Data Management (CDM) teams and cross-functional stakeholders.

Drive continuous process improvement initiatives and support organizational change efforts across the portfolio.

Apply advanced knowledge of database structures, validation methodologies, and testing processes.

Provide support to the Testing Lead and contribute to project documentation and stakeholder communications.

Act as deputy or backup for the Testing Lead when required.

Serve as a Subject Matter Expert (SME) for database validation and testing activities.

Mentor, train, and support onboarding of new team members.

Attend and actively contribute to project and study team meetings.

Review project plans and proactively identify, escalate, and mitigate risks and issues.

Provide end-to-end project management for testing activities, including resource planning, workload management, and delivery oversight.

Monitor project timelines and ensure testing deliverables are completed within agreed deadlines.

Conduct quality reviews and audits to ensure compliance with study requirements and regulatory standards.

Develop and maintain strong relationships with internal customers and key stakeholders.

Support risk management activities by identifying potential challenges and escalating concerns to management.

Contribute to process optimization and implementation of best practices within the testing and validation function.

Ensure accurate documentation, tracking, and reporting of testing outcomes and validation findings.

Support successful database build, testing, deployment, and maintenance activities throughout the clinical trial lifecycle.

Qualifications

Bachelor's Degree Clinical, biological or mathematical sciences, or related field
Equivalent combination of education, training and experience in lieu of degree.
Medical terminology exposure.

Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Medical terminology exposure.

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.