Manager, Clinical Data Innovation

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Lead the implementation of innovative processes and technologies for analyzing and trending clinical trial data throughout the study phase.

• Oversee the comprehensive execution of clinical studies on the clinical data platform, which includes vendor RFP assessments, data imports, user acceptance testing, and the delivery of both standard and custom listings and visualizations.

• Provide guidance to cross-functional clinical trial teams on effectively utilizing the clinical data platform to meet goals related to data review, medical monitoring, and risk management plans.

• Assist in the development of software systems and related infrastructure to ensure efficient and user-friendly displays of clinical study data and metrics reports.

• Work collaboratively with external vendors and data managers to streamline the acquisition of clinical data into the platform.

• Share best practices for application usage and implement solutions to enhance the adoption and effectiveness of the clinical data platform.

• Identify and execute continuous improvement initiatives for the Clinical Data Innovation team's processes.

• Program QlikSense visualizations that provide insights into clinical trial start-up and execution.

• Configure and program centralized data monitoring methods that support risk-based quality management.

• Assist with the ongoing development and software updates of the clinical data platform, ensuring that deliverables align with user requirements and GxP standards.

⛳️ Requirements

• Bachelor's or Master's Degree in Biology, Mathematics, Computer Science, or a related field.

• 3-5+ years of relevant professional experience, including clinical trial execution and/or clinical systems implementation.

• Comprehensive understanding of clinical trial planning, initiation, and execution concepts, along with the challenges that can be addressed through data visualizations.

• Exceptional verbal and written communication skills, particularly in explaining technical concepts to non-technical audiences and translating business requirements for technical programmers.

• Strong analytical and problem-solving abilities with a focus on clinical data and technical/data issues.

• Experience in gathering requirements and documenting them for dashboards, reports, or data review listings using agile methodologies/principles.

• Capability to prioritize and manage multiple tasks concurrently within a cross-functional team environment.

• Deep understanding of regulatory, industry (GCP), and technology standards and requirements, including ICH E6, Regulatory Guidelines, and SDLC.

• Familiarity with the elluminate platform is advantageous.

• Experience in advanced analytics, including machine learning techniques applied to clinical trials, is a plus.

• Proficiency in T-SQL, QlikSense, R, or Python is a plus.

• Knowledge of ICH E6 (R2) Risk-Based Quality Management is a plus.

• Experience in supporting or conducting centralized statistical monitoring is a plus.

🏝️ Benefits

• Discretionary annual cash bonus or incentive compensation.

• Discretionary equity grants.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401k retirement savings plan.

• Flexible paid vacation.