What are the responsibilities and job description for the Senior Clinical System Analyst position at Tundra Technical Solutions?
Job Title: Senior Clinical Systems Analyst – Clinical Business Operations (Contractor, Full-Time)
Level: Senior Manager to Associate Director (based on experience)
Location: Remote (Preference for candidates local to Cambridge, MA, with monthly office visits)
About the Role
We’re seeking a Senior Clinical Systems Analyst to join the Clinical Business Operations – Clinical Systems group. In this role, you will help drive the adoption of our clinical data warehouse, serving as the primary liaison between the system implementation team and end users. You’ll translate requirements, support system build and testing, and enable user adoption to ensure the technology delivers its full potential.
This is a contractor position, full-time, scoped at the Senior Manager to Associate Director level depending on experience.
What You’ll Do
- Gather and translate user requirements into system specifications.
- Develop documentation for system implementation, user training, and communications.
- Support validation activities including test planning, script review, and UAT execution.
- Partner with end users to drive adoption and provide training across clinical development functions.
- Collaborate with cross-functional stakeholders to maximize the value of the clinical data warehouse.
- Stay current with industry trends to help shape future system enhancements.
What We’re Looking For
- Education: BA/BS in a scientific, healthcare, or technology field.
- Experience: 5 years (Sr. Manager) or 8 years (Assoc. Director) in clinical systems within pharma/biotech.
- Strong knowledge of clinical data processes, EDC, external data management, SDTM/patient profiles, and data review.
- Experience with clinical technologies such as Microsoft-based applications, Veeva Clinical Vault, and (ideally) eClinical Solutions elluminate.
- Expertise in GxP compliance, computer systems validation, and familiarity with FDA/ICH guidelines, 21 CFR Part 11, and GAMP 5.
- Excellent communication skills with the ability to work across technical and non-technical stakeholders.
- Consulting or client-facing experience preferred.
Key Skills
- Clinical study management expertise
- System implementation & validation (SDLC, CSA)
- Project management & cross-functional collaboration
- Training & end-user adoption
- Strong documentation and organizational skills
This is an exciting opportunity to help build and optimize clinical systems that directly impact the success of clinical trials.
Salary : $90 - $95
