eCOA Build Programmer

Overview

The eCOA Build Programmer designs, programs and tests clinical trial data collection databases, including mapping, testing and normalization of data into a clinical data warehouse, and collaborates with Data and Analytics colleagues to deliver standardized data collection methods and validation solutions for global clinical trials.

What you'll do

• Gather and influence eCOA design specifications from the Clinical Trial Protocol to enable successful trial design and implementation.
• Build, program and test clinical trial data collection systems (eCOA database) and associated data repository mappings for a trial or set of trials within a program using data standards library components.
• Ensure clinical data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives.
• Partner with translation vendors to implement localized data collection in country-specific language.
• Partner with the Clinical Build Programmer to ensure complete data build for trial data collection needs.
• Provide insights into study-level deliverables (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.
• Develop and test new ideas and/or apply innovative solutions that add new value to the portfolio.
• 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 the database.
• Partner to deliver the study database per business need and before first patient visit.
• Follow and influence data standard decisions and strategies for a study and/or program.
• Utilize therapeutic knowledge and a deep understanding of the technology used to collect clinical trial data.
• Apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, privacy knowledge, etc.) to study build deliverables.
• Integrate multi-functional and/or external information and apply technical knowledge to data-driven decision making.
• Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable normalization of various data sources into a common data repository.
• Represent Data and Analytics processes in multi-functional initiatives.
• Actively engage in shared learning across the Data and Analytics organization.
• Increase re-usability of screens and edits by improving the initial design.
• Reduce post-production changes through the change control process.
• Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization.
• Interact with regulators, business partners and outside stakeholders on business issues.
• Think end to end, consistently managing risk to minimize impact on delivery.
• Build a diverse multi-functional and internal/external network to understand how different disciplines and approaches contribute to research and development.
• Define database solutions and timelines in support of advancing the portfolio.

What you'll need

• Bachelor's or Master's degree in computer science, engineering, medical field, Informatics, Life Sciences, Statistics, or Information Technology, with hands-on experience in database programming, or a combination of clinical data management, system validation and data analysis.
• Experience in the clinical, pharmaceutical, biotech, CRO or regulatory agency sectors.
• Working experience in eCOA (electronic Clinical Outcome Assessment) or eDC (electronic data capture), eSource or Direct Data Capture implementation.
• Design of electronic CRF screens to capture clinical data and build required validations.
• Understanding of clinical protocols and interpretation of clinical terminologies to create or design specifications.
• Familiarity with clinical data tools, technologies, workflow for collecting patient data, and testing and validation of systems.
• Analyse the impact and implement post-production changes to the study design.
• Data analytics and visualizations.
• Articulate the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions.
• Decide the technology platform (system/database) for data acquisition and aggregation.
• Utilization of clinical/drug development knowledge and ability to liaise effectively with study team members (i.e., Data Sciences, Statistics, PK, Operations, Medical).
• Strong therapeutic/scientific knowledge in the field of research.
• Project management experience.
• Vendor management experience.
• Understanding of and experience in using data standards.
• Knowledge of medical terminology.
• Ability to balance multiple activities, prioritize and manage ambiguity.
• Demonstrated exemplary teamwork/interpersonal skills.
• Proven problem solving, attention to detail and results-oriented behaviors in a fast-paced environment.

Nice to have

• Programming experience with HTML, CSS, JavaScript, Node.js, JSON.
• Experience with relational and non-relational database technologies utilizing SQL, data functions and procedures.
• Technical proficiency with HTML, data mapping, and understanding of database structures.
• Experience handling GitLab utilities.
• Quick learner of new trends in technology.
• Excellent leadership, communication (written and oral) and interpersonal skills.
• Demonstrated leadership in a professional setting.
• Demonstrated teamwork and collaboration in a professional setting.

Details

• Location: Bengaluru, India.
• Domestic and international travel may be required.