Position Overview:
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.
Key Responsibilities:
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.
Key Qualifications:
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.
Preferred Experience:
Experience in a Research IT setting within the biopharma industry. Knowledge of system validation and data integrity best practices for research and clinical environments.
