Business System Analyst Clinical

2 weeks ago


Cambridge, United States Boston Technology Full time

We are looking for a Business System Analyst to gather requirements, UAT, and create presentations.

Strong understanding and working knowledge of: GxP Regulations (FDA, EMA, ICH), including FDA 21 CFR Part 11, ICH E6(R2)

Clinical Trial Data (STDM, ADaM, DTD, eCTD/XML)

Implementing data platforms and services.

Experience selecting, designing and implementing IT Applications

pharmaceutical/biotech with experience in clinical development.

Custom developed cloud-based solutions

Regulated systems in a GxP regulated industry

Please submit for more detailed JD.

Pay: $54.71 - $70.85 per hour

Schedule:

- Monday to Friday

**Experience**:

- GxP regulated: 2 years (required)
- Clinical development: 2 years (required)

Ability to Commute:

- Cambridge, MA 02142 (required)

Work Location: In person



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