Clinical Database Analyst

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.

POSITION SUMMARY:

Responsible for visualizing clinical trial data in SPOTFIRE for the Analytical Risk-based Monitoring (ARBM) group and for the medical reviewers in the iDARTs application (an internally developed tool for medical review of clinical trial data based on TIBCO’s Spotfire).

PRINCIPAL RESPONSIBILITIES: % OF TIME

• Visualizations for ARBM Group:

o Load/Configure SAS output provided by ARBM programmers in SPOTFIRE template

o Create data visualizations (Tables/Graphs) in SPOTFIRE based on ad-hoc requirements.

o Generate user requirements documentation and setup UAT

o Move visualizations to production through the development stages (dev/qa/prod) per existing process

• Visualizations for Medical Review

o Load the clinical trial datasets (in Study Data Tabulation Model) in Spotfire/iDARTs

o Map existing data visualization templates in iDARTs to the clinical trial datasets

o Collect additional user requirements (from study physicians & data managers) and design new visualizations (Tables/Graphs)

o Design new visualizations (Tables/Graphs) based on the user requirements

o Conduct review sessions with the study team members

o Follow-up on needed improvements and changes needed

o Move visualizations to production through the development stages (dev/qa/prod) per existing process 50%

DECISION-MAKING AND PROBLEM-SOLVING:

Position requires an open mindset with good issue identification and problem-solving skills. A degree of straightforward decision making is expected, while balancing the need for further escalation of issues that require more complex decisions.

WORKING RELATIONSHIPS/INTERFACES:

Primarily interacts with

• ARBM team members (SAS Programmers and Central Monitors)

• Clinical study team members (Clinical Scientist, Study Physician, Global Data Manager)

• As needed, interacts with other staff within R&D (eg, biostats & programming)

EDUCATION & EXPERIENCE REQUIREMENTS:

• Minimum of a BS/BA degree or professional experience equivalent

• At least 1 year relevant experience in pharmaceutical or health care industry

• Advanced knowledge of TIBCO Spotfire required

• Experience in working with clinical data (plus a general understanding of clinical trials) strongly preferred

QUALITIES AND CHARACTERISTICS:

• Communication skills and active listening

• Strong customer focus

• Strong analytical mindset & Quality oriented