Data Quality Analyst

• 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

• 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).

Thanks!!

With Regards,

Kavita Kumari

Clinical Recruiter

Awarded “TALENT MAGNET”

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Inc. 5000 – 2007-2014 (8th Year)

Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70

Direct: 732 - 662 - 5619

Tel: 732-549-2030 x 326

Fax: 732-549-5549

www.irionline.com

https://www.linkedin.com/in/rkavita