Clinical Database Analyst
- Compensation
- Not disclosed
- Location
- Lexington, MA, us
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- Not specified
- Category
- Not specified
- Posted
Skills
Full 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)
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