The electronic Clinical Outcomes Assessment (eCOA) Build Programmer is responsible for designing, programming and testing clinical trial data collection databases, including the mapping, testing and normalization of data into a clinical data warehouse. This requires an in depth understanding of data technology, data flow, data standards, database programming, normalization and testing. This role will collaborate with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Manager, Statistician and other key partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials.
Responsibilities:
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Portfolio Delivery:
- Gather and influence eCOA design specifications to enable successful trial implementation
- 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
- Ensure 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
- Partner with Clinical Build Programmer to ensure complete data build for trial data collection needs
- Provide insights into study level deliverables (ie, 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
- Opportunity to develop and tests new ideas and/or applies innovative solutions that add new value to the portfolio
Project Management:
- Increase speed, accuracy, and consistency in the development of systems solutions
- Enable metrics reporting of study development timelines and pre and postproduction changes to database
- Partner to deliver 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 possess a deep understanding of the technology used to collect clinical trial data
- Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc) to study build deliverables
- Integrates multi-functional and/or external information and applies technical knowledge to data-driven decision making.
- Enterprise Leadership:
- 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
- Represent Data and Analytics processes in multi-functional initiatives
- Actively engage in shared learning across Data and Analytics organization
- Work to Increase re-usability of screens and edits by improving the initial design
- Work to reduce postproduction changes change control process
- Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization
- Interacts with regulators, business partners and outside stakeholders on business issues
- Thinks with end to end in mind consistently managing risk to minimize impact on delivery
- Builds a diverse multi-functional and internal/external network to understand how different disciplines and approaches contribute to research and development
- Focuses on defining database solutions and timelines in support of advancing the portfolio
Basic Qualifications & Requirements: - bachelors or masters degree in computer science, engineering, medical field, Informatics, Life Sciences, Statistics, 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.
- 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 on required validations
- Understanding of Clinical Protocol and interpretation of the Clinical terminologies to create or design specifications
- Familiarity with Clinical data tools, technologies, workflow for collecting patient data, testing and validation of system
- Analyse the impact and implement post production changes the Study design
- Data analytics and visualizations
- Articulating the flow of data (structure and format) from patient to analysis and apply 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 effectively with study team members (ie, Data Sciences, Statistics, PK, Operations, Medical)
- Strong therapeutic/scientific knowledge in the field of research
- Project management experience
- Vendor management experience
- Understanding 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 result oriented behaviors in a fast-paced environment.
Additional Preferences:
- Programming experience with HTML, CSS, JAVASCRIPT, Node.js, JSON.
- Experience with relational and non-relational database technologies utilizing SQL, Data Functions and Procedures. (e.g., MongoDB)
- Technical proficiency with HTML, Data Mapping, understanding of database structures, etc
- Experience handling GITLAB utilities
- Quick learner to new trends in technology
- Excellent leadership, communication (written and oral) and interpersonal skills
- Demonstrated leadership in professional setting
- Demonstrated teamwork and collaboration in a professional setting
Other Information:
- Domestic and International travel may be required
