Data Quality Analyst

Data Quality Analyst

IRI believes in commitment, integrity and strategic workforce solutions.

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.

Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients' success.

Job Description

• Review and/or create user acceptance test (UAT) plan/ scripts for quality and completeness of electronic data capture (EDC) systems including Electronic Clinical outcome assessment (eCOA) systems.

• Perform UAT (Screen setup testing and Edit checks testing) to ensure high quality EDC / eCOA system setup, compliance with industry and best practices.

• Schedule and lead meeting to provide feedback on the UAT issues to the project team (internal/vendor).

• Reviews study documentation ensuring data quality is consistent with DM best practices, standards and procedures

• Communicate lessons learned and recommend process improvements

• Ensure DM activities are completed by vendors according to specified quality standards

Qualifications

• Strong understanding of end to end Clinical Data Management in a biotech or pharma environment (minimum experience: 5 years)

• Experience working with DM vendors and CROs highly desirable

• Familiarity with Medidata RAVE/Inform and/or other clinical data management software preferred

• Experience writing UAT plan/ scripts and executing UAT scripts for testing of electronic data capture systems including eCOA(Electronic Clinical outcome assessment) systems, to ensure that all clinical trial databases and electronic collection tools are consistent with the needs of the study protocol and department standards and procedures

• Solid working knowledge of MS Outlook, MS Word, MS Excel, MS PowerPoint

• Knowledge of GCP and other regulations.

• Must have excellent oral and written communication / presentation / negotiation skills.

• Ability to manage multiple (changing) priorities under tight timelines

• Detail oriented, able to identify issues and consistently collaborate to solve problems in a timely manner

• Internal/external customer management, influence of peers, team effectiveness and enhancement, timeline management, proactive problem solving ability, ability to develop trust, shared goals and values.

• Collaboration, with negotiation skills, conceptual thinking, systems process thinking, accountability to deliverable milestones, conflict resolution (internal and external).