DESCRIPTION:
The Business Analyst is the liaison between the Science, Sponsor and Data Management teams. The Business Analyst understands the imaging and clinical data analysis system data export format, Sponsors data requirements for both incoming and outgoing data and translates them to data management software requirements.
RESPONSIBILITIES & ACCOUNTABILITIES:
- Converts high-level information contained in documentation e.g. charter and other analysis requirement documents and data transfer specification templates, into detailed standardized data export requirement specifications.
- Serves as the conduit between the customer community (internal and external stakeholders) and the data management development team through which requirements flow.
- Works with Science, Data Management, and Innovation team to ensure they fully understand the Voiant analysis software export formats.
- Proactively communicates and collaborates with internal and external stakeholders to finalize requirements using interviews, document analysis, requirements workshops, surveys, business process descriptions, use cases, scenarios, business analysis, and task and workflow analysis.
- Collaborates with data programmers and subject matter experts to reconcile conflicts and analyze tradeoffs between requirements and system functionality.
- Designs and delivers artifacts to assist in data programming activities, including user requirements specifications, workflow diagrams, form/report designs and functionality, and report layouts.
- Displays excellent verbal and written communication skills, and the ability to interact professionally with a diverse group, including executives, managers, and subject matter experts.
- Adapts to new technical challenges, building off a strong existing knowledge base to complete tasks using new methods, languages, and applications as needed.
EDUCATION & EXPERIENCE
Basic requirements:
- Minimum of bachelor’s degree, preferably in Bioengineering, Statistics, Computer Science, or Bioinformatics
- 4+ years of experience in a business systems analyst role related to clinical data management in a CRO or pharmaceutical industry preferred.
- Strong CDISC, SDTM or ADaM standard experience
- Strong project management, written and verbal communication and organizational skills.
- Self-motivated individual with strong interpersonal skills
- Understanding of clinical trial imaging data formats and data structures in different therapeutic area clinical trials (e.g. Oncology, respiratory, cardiology)
- Understanding of imaging modalities and clinical trial read criteria (e.g., RECIST 1.1, RANO, Lugano; safety endpoint adjudication) preferred.
- Ability to manage multiple priorities and handle multiple projects simultaneously.
- Ability to troubleshoot problems quickly and effectively and escalate where needed.
Desired qualifications:
- Knowledge of clinical trial management
- Knowledge of software guidance within GxP/FDA regulated industry
This is a paid full-time position with opportunities for professional growth and development. Join us in this exciting opportunity to make a significant impact through data-driven insights!
Job Type: Full-time
Pay: $60,000.00 - $70,000.00 per year
Benefits:
- 401(k)
- 401(k) 3% Match
- AD&D insurance
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Paid holidays
- Paid time off
- Vision insurance
- Work from home
Experience level:
Schedule:
- 8 hour shift
- Monday to Friday
People with a criminal record are encouraged to apply
Work Location: Remote