Senior Clinical Systems Analyst

Overview

On Site
Hybrid
BASED ON EXPERIENCE
Contract - W2
Contract - Independent
Contract - 9+ mo(s)

Skills

Mergers and Acquisitions
FOCUS
End-user Training
Specification Gathering
Software Design
Documentation
Project Implementation
Training
User Guides
Project Documentation
Test Plans
Data Migration
Status Reports
RAID
Test Scripts
Acceptance Testing
Collaboration
Data Warehouse
Mentorship
Clinical Data Management
Regulatory Compliance
Pharmaceutics
GxP
System Implementation
GAMP
Customer Facing
Microsoft
Veeva
EDC
Data Management
SDTM
Workflow
Project Management
Communication
Management
Attention To Detail
Adaptability
Artificial Intelligence
Privacy
SANS

Job Details


Duration: 9 months
Pay: $70-93/hr.
Location: Hybrid - Cambridge, MA (Mostly remote; preference for local candidates able to be onsite 2 days/month as needed. Fully remote considered.)

The Senior Clinical Systems Analyst will serve as the primary liaison between end users and the clinical data warehouse implementation team, supporting the adoption of clinical technologies that improve trial management, data review, and analysis. This role will focus initially on the implementation and adoption of the clinical data warehouse, while also providing support for other clinical systems as needed.
You will gather requirements, contribute to system specifications, lead user acceptance testing, and support user training and adoption. The ideal candidate will have deep expertise in GxP systems, clinical data processes, and compliance standards, combined with excellent project management and consulting skills.

Key Responsibilities

  • Gather user requirements and translate them into detailed technical specifications for solution design and implementation.
  • Develop documentation for project implementation, including user access/training plans, communication materials, and end user guides.
  • Support validation and project documentation (configuration workbooks, test plans, test scripts, data migration plans, status reports, RAID logs, etc.).
  • Lead and execute test scripts, facilitate UAT, and ensure successful adoption across clinical development functions.
  • Collaborate cross-functionally to optimize use of the clinical data warehouse.
  • Train and mentor end users to maximize technology adoption and efficiency.
  • Partner with delivery teams to identify solutions that align with industry trends and best practices in clinical data management.
  • Maintain compliance with FDA/ICH guidelines, 21 CFR Part 11, GAMP 5, and other regulatory standards.
Required Qualifications
  • Bachelor s degree required
  • 5+ years of clinical technology/clinical systems manager-level experience within the pharma/biotech industry - required
  • GxP systems implementation and support experience - required
  • Knowledge of 21 CFR Part 11, GAMP 5, and related FDA regulations - required
  • Veeva Clinical Vault or eClinical solutions like elluminate is preferred
  • Consulting background with recent client-facing experience.
  • Proficiency with Microsoft applications, Veeva Clinical Vault, and (ideally) eCS elluminate.
  • Understanding of clinical data processes: EDC setup, external vendor data management, SDTM/patient profile creation, and clinical data review workflows.
  • Strong project management methodology knowledge, with ability to partner effectively with assigned Project Managers.
Preferred Skills
  • Excellent interpersonal, written, and verbal communication skills, with ability to interface effectively with both technical and non-technical stakeholders.
  • Strong organizational and time management abilities with a proven ability to manage multiple priorities.
  • Quality-driven, detail-oriented, and proactive.
  • Flexible, adaptable, and capable of working in a fast-paced, matrixed environment.
  • Passionate about leveraging technology to transform clinical development processes.
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