eCOA - Clinical Study Build Programmer

About the role

The Clinical Study Build Programmer - eCOA is responsible for programming and testing clinical trial data collection databases, including the mapping, testing and normalization of data into a clinical data warehouse. This role requires an in-depth understanding of data technology, data flow, data standards, database programming, normalization and testing.

Responsibilities

• Collaborate with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Manager and other key business partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials.
• Portfolio Delivery: Proficiency in programming and configuring clinical data collection systems (e.g., eCOA/EDC platforms).
• Study build programming expertise (e.g., form logic, edit checks, workflows, integrations).
• Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library components.
• Gather and influence eCOA design specifications and enable successful implementation.
• Ensure data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives.
• Provide insights into the study design and data delivery (i.e. Data Management Plan, Project Plan, database, and observed datasets).
• Support submission, inspection and regulatory response activities.
• Lead cross Business Unit/Therapeutic Area projects or programs with high complexity.
• Develops and tests new ideas and/or applies innovative solutions.
• Project Management: Increase speed, accuracy, and consistency in the development of systems solutions. Enable metrics reporting of study development timelines and pre and post production changes to database.
• Partner with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Management Associate to deliver study database per business need and before first patient visit.
• Influence data standard decisions and strategies for a study and/or program.
• Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to study database building.
• Integrate multi-functional, external information and technical knowledge to support data-driven decision making.
• Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and downstream analysis.
• Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization.
• Think with end to end in mind consistently managing risk to minimize impact on delivery.
• Strong awareness with external developments, timelines.
• Focuses on defining database solutions and timelines in support of advancing the portfolio.

Qualifications

• Master’s degree in a scientific field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, Computer Sciences + 3 years of related experience (or bachelor’s degree plus 5 or more years of experience in clinical data management or areas that closely intersect with clinical data management e.g., statistics, data analytics, information technology, health outcomes, etc...)
• Experience with designing and handling eCOA data.
• Articulating the flow of data (structure and format) from patient to analysis, applying this knowledge to data solutions.
• Deciding the technology platform (system/database) for data acquisition and aggregation.
• Utilization of clinical/drug development knowledge and an ability to liaise with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical, etc.).
• Strong therapeutic/scientific knowledge in the field of research.
• Familiarity with clinical data tools and technologies.
• Ability to balance multiple activities, prioritize and manage ambiguity.