Laboratory Research Assistant conducting data collection for clinical device trials at UHS locations in New York. Responsible for maintaining data integrity and compliance with research protocols.
About the role
- Associate Principal Scientist responsible for planning and executing biomarker operations for clinical trials at a global healthcare leader. Supporting drug development through operational excellence in Immunology and Oncology.
Responsibilities
- Responsible for planning and executing clinical-trial biomarkers across the pipeline
- Ensuring compliant, efficient biospecimen collection, assay execution, and data delivery
- Drive operational excellence, data quality, and compliance across the biomarker assay project lifecycle
- Partner closely with scientific and operational colleagues to support a cohesive and agile team that delivers high-quality biomarker data for clinical trials and translational research
- Collaborate closely with biomarker scientists and study teams to plan clinical-trial biomarker set-up and logistics
- Serve as the operational partner to Biomarker Leads, helping implement strategies that advance biomarker programs
- Co-author biomarker-related sections of clinical study protocols
- Collaborate with Translational Molecular Biomarker Scientists to define and manage specimen collection, handling, shipping, storage, and processing requirements
- Develop biomarker vendor statements of work and data-transfer specifications in partnership with clinical teams
- Work with clinical teams to coordinate sample and assay logistics, issue resolution and risk mitigation
- Partner with Data Management to transfer biomarker data from external vendors into the clinical data repository
- Work with clinical teams and central laboratories to design sample collection kits, laboratory manuals, and specimen logistics for shipments to third-party vendors
- Build and maintain effective partnerships with external biomarker vendors and internal company teams
- Proactively identify and resolve conflicting stakeholders needs to maintain alignment and momentum
- Implement and continuously improve streamlined workflows that maximize efficiency and data quality and reinforce a culture of operational excellence.
Requirements
- Bachelor’s degree (with ≥8 years of relevant experience), Master’s degree, or higher (with ≥5 years of relevant experience) in a scientific or technical field.
- Demonstrated project management experience.
- Proven experience in drug discovery and/or clinical research.
- Demonstrated ability to excel in fast-paced, evolving conditions and advocate for operational excellence.
- Excellent written and verbal communication skills, with the ability to work independently within a highly collaborative, matrixed environment.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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