Clinical Database Analyst

Job Description

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)

Qualifications

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

• Innovative thinking

• Flawless execution

Additional Information

Kind Regards,

Daniel Jagota

Technical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

DIRECT  732-429-1919 

daniel @irionline.com