Job Description
Position Overview:
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We are seeking a skilled Scientific Business Analyst to join our client's Research IT team at a leading biopharma company. The ideal candidate will have experience working with Laboratory Information Management Systems (LIMS) within the Clinical and Preclinical Sample Management space and be well-versed in regulatory compliance as it relates to LIMS implementations. This role requires an independent, self-motivated professional capable of translating complex scientific and regulatory requirements into actionable IT solutions that align with business objectives.
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Key Responsibilities:
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- Collaborate with cross-functional teams, including scientists, researchers, and IT professionals, to gather, analyze, and document business requirements for LIMS implementation and optimization.
- Provide expert-level support in Clinical and Preclinical Sample Management, ensuring LIMS configurations meet scientific, operational, and regulatory needs.
- Ensure compliance with relevant regulatory standards (e.g., FDA, EMA) throughout LIMS implementation, including data integrity, security, and validation requirements.
- Conduct process analysis and provide recommendations for improving workflows related to sample management, data handling, and reporting.
- Act as a liaison between business stakeholders and technical teams, facilitating clear communication to ensure successful project delivery.
- Independently manage project deliverables, timelines, and documentation, while driving progress toward key milestones.
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Key Qualifications:
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- Strong familiarity with LIMS platforms in the Clinical and Preclinical Sample Management space.
- In-depth understanding of regulatory compliance, especially in the context of LIMS and biopharma research environments.
- Proven ability to work independently, manage multiple priorities, and deliver high-quality results in a fast-paced environment.
- Excellent analytical, problem-solving, and communication skills with the ability to work collaboratively with both technical and non-technical stakeholders.
- Bachelor's degree in Life Sciences, Information Technology, or a related field; advanced degree preferred.
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Preferred Experience:
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- Experience in a Research IT setting within the biopharma industry.
- Knowledge of system validation and data integrity best practices for research and clinical environments.
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