Senior Clinical Systems Analyst - Contract - Cambridge, MA
Proclinical is seeking a Senior Clinical Systems Analyst to support clinical systems and data management processes within the pharmaceutical industry. The position offers an exciting opportunity to contribute to advances in immuno-oncology.
Primary Responsibilities:
The successful candidate will focus on gathering user requirements, creating technical documentation, and collaborating with cross-functional teams to enhance clinical data workflows.
Skills & Requirements:
- Proficiency with digital systems, including Microsoft-based applications and Veeva Clinical Vault; experience with eCS and elluminate is a plus.
- Strong background in clinical study management activities, GxP compliance, and clinical data processes (e.g., EDC setup, external data management, SDTM creation).
- Familiarity with FDA/ICH guidelines, 21 CFR Part 11, and industry standards for clinical trial data management.
- Experience with project management methodologies and tools, including RAID logs and status reporting.
- Excellent interpersonal, written, and verbal communication skills for engaging both technical and non-technical stakeholders.
- Ability to work independently, prioritize tasks, and manage multiple projects in a matrix environment.
- Knowledge of GAMP 5, Computer Systems Assurance, and Software Development Life Cycle (SDLC) models.
- Bachelor's degree in a scientific, healthcare, or technology field preferred.
The Senior Clinical Systems Analyst's responsibilities will be:
- Gather and translate user requirements into detailed technical specifications for solution design and implementation.
- Develop project documentation, including user access plans, training materials, communication plans, and end-user guides.
- Support validation and project management documentation, such as configuration workbooks, system impact assessments, test plans, and data migration plans.
- Review and execute test scripts, facilitate user acceptance testing (UAT), and provide training to end users to enhance adoption.
- Collaborate with stakeholders across clinical development functions to optimize the use of clinical data warehouses.
- Partner with delivery teams to define solutions that align with industry trends in clinical data management.
If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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