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Work Location Irvine, CA (Hybrid)
Assignment Duration 12 Months
Position Summary Perform quantitative analysis using Python (e.g., pandas, NumPy, visualization libraries) to support clinical trial operations such as enrollment, costing, and resourcing, and to develop forecasting and decision-support outputs for key stakeholders (e.g., Clinical Affairs, Regulatory and Medical Affairs, Strategy, Global Supply Chain, Finance).
Investigate, assess, and interpret clinical and operational data to support strategic decision-making, including early signal detection related to enrollment trends, protocol adherence, site performance, and data quality, while proposing moderately complex solutions and recommendations.
Key Responsibilities
Perform quantitative analysis using Python (e.g., pandas, NumPy, visualization libraries) to support clinical trial operations such as enrollment, costing, and resourcing, and to develop forecasting and decision-support outputs for key stakeholders (e.g., Clinical Affairs, Regulatory and Medical Affairs, Strategy, Global Supply Chain, Finance).
Investigate, assess, and interpret clinical and operational data to support strategic decision-making, including early signal detection related to enrollment trends, protocol adherence, site performance, and data quality, while proposing moderately complex solutions and recommendations.
Modify, extend, and maintain analysis tools and workflows—primarily in Python—by leveraging existing clinical models (e.g., inventory, case management, headcount, trial enrollment, site activations/deactivations) while applying clinical trial domain knowledge.
Organize, analyze, and create reproducible analyses, reports, dashboards, and data extracts to summarize moderately complex challenges across clinical affairs projects, programs, and initiatives.
Apply statistical methods (e.g., descriptive statistics, trend analysis, basic inferential methods) as appropriate to quantify uncertainty, monitor performance, and support interpretation of clinical and operational signals.
Lead portions of clinical analytics projects in collaboration with cross-functional stakeholders (e.g., Clinical Operations, Biostatistics, vendors, and internal analytics partners).
Identify and propose data-driven process improvements related to clinical affairs operations (e.g., screening efficiency, site start-up, physician training, data review workflows).
Other duties as assigned.
Qualification & Experience
Bachelor's Degree Required
3 years of previous related experience Required
Experience in a quantitative, analytical, or programming-heavy role Preferred
Experience working in clinical research or clinical trial operations within the medical device industry Preferred
Strong proficiency in Python for data analysis, including developing maintainable scripts and notebooks for clinical and operational datasets
Proven expertise in Excel and PowerPoint and other MS Office Suite applications (Word, Access)
Solid understanding of quantitative and statistical methodologies, with the ability to apply them pragmatically in a clinical operations context
Experience with signal detection, trend monitoring, or anomaly identification in complex datasets preferred
Good written and verbal communication skills and interpersonal relationship skills
Strong problem-solving, organizational, analytical, and critical-thinking skills
Moderate knowledge and understanding of client's policies, procedures, and guidelines relevant to clinical trial data analytics
Strict attention to detail and data quality
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Ability to work collaboratively in team and cross-functional environments
Ability to build productive internal and external working relationships
Adhere to all company rules and requirements (e.g., Environmental Health & Safety policies) and take appropriate measures to protect people, data, and the environment.
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Sprachkenntnisse
- English
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