Clinical Trial Database Analyst (Spotfire)

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.

• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Title: Clinical Trial Database Analyst (SPOTFIRE)

Duration: 12-24 months

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:

• Visualizations for ARBM Group:
• Load/Configure SAS output provided by ARBM programmers in SPOTFIRE template
• Create data visualizations (Tables/Graphs) in SPOTFIRE based on ad-hoc requirements.
• Generate user requirements documentation and setup UAT
• Move visualizations to production through the development stages (dev/qa/prod) per existing process
• Visualizations for Medical Review
• Load the Clinical Trial datasets (in Study Data Tabulation Model) in Spotfire/iDARTs
• Map existing data visualization templates in iDARTs to the Clinical Trial datasets
• Collect additional user requirements (from study physicians & data managers) and design new visualizations (Tables/Graphs)
• Design new visualizations (Tables/Graphs) based on the user requirements
• Conduct review sessions with the study team members
• Follow-up on needed improvements and changes needed
• 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
• Advanced knowledge of TIBCO Spotfire required
• Experience in working with clinical data (plus a general understanding of Clinical Trials)

All your information will be kept confidential according to EEO guidelines.