Clinical Study Build Programmer

This is a fully remote position, open to applicants in United States.

📋 Description

• Design and evaluate clinical trial data collection databases, encompassing mapping, testing, and normalization into a clinical data warehouse.

• Set up clinical data collection systems, including eCOA/EDC platforms.

• Create study forms, logic, edit checks, workflows, integrations, and data repository mappings.

• Collect and influence eCOA design specifications while assisting in implementation.

• Recognize study translation requirements and facilitate localization.

• Ensure precise data collection systems and data warehouse mappings that align with study goals.

• Offer insights regarding study design and data delivery, covering the Data Management Plan, Project Plan, database, and observed datasets.

• Assist in submission, inspection, and regulatory response activities.

• Oversee intricate cross-Business Unit/Therapeutic Area projects or programs.

• Innovate and test new solutions.

• Enhance development speed, accuracy, consistency, and the study build cycle time.

• Enable metrics reporting for study development timelines and database modifications.

• Collaborate with Data and Analytics colleagues to deliver study databases prior to the first patient visit.

• Impact data standard decisions and strategies.

• Implement regulatory and privacy requirements in the development of study databases.

• Synthesize multifunctional, external, and technical information for data-driven decision-making.

• Minimize postproduction changes via change-control processes.

• Proactively identify and resolve technical, operational, and business challenges that affect Data and Analytics.

• Manage delivery risks and outline database solutions and timelines for the portfolio.

⛳️ Requirements

• Master’s degree in a scientific discipline such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, or Computer Sciences, along with 3 years of relevant experience.

• Alternatively, a bachelor’s degree with 5 or more years of experience in clinical data management or related fields.

• Proficiency in designing and managing eCOA data.

• Ability to clearly explain data flow from patient to analysis and apply this understanding to data solutions.

• Experience in selecting technology platforms for data acquisition and aggregation.

• Knowledge of clinical/drug development and the ability to connect with study team members.

• Strong therapeutic/scientific expertise in the research domain.

• Familiarity with clinical data tools and technologies.

• Understanding and experience with data standards.

• Capability to juggle multiple tasks, prioritize effectively, and manage uncertainty.

• Domestic and international travel may be necessary.

• Awareness of applicable internal, external, and regulatory requirements/expectations, including MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, and privacy regulations.

🏝️ Benefits

• Company bonus based partly on individual and company performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.

• Life insurance and death benefit options.

• Leave of absence and time off benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and various employee clubs and activities.

• Employee resource groups providing support networks.