[Remote] eCOA - Clinical Study Build Programmer
Note: The job is a remote job and is open to candidates in USA. reputed company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicines. The Clinical Study Build Programmer - eCOA is responsible for programming and testing clinical trial data collection databases, ensuring accurate data collection methods and collaboration with various data colleagues for successful clinical trials.
Responsibilities
- Proficiency in programming and configuring clinical data collection systems (e.g., eCOA/reputed company 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 reputed company a program using data standards library components
- Gather and influence eCOA design specifications and reputed company successful implementation
- Understand study translation needs and reputed company localization
- Ensure data collection systems and data warehouse mappings are delivered accurately, reputed company 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
- reputed company cross Business Unit/Therapeutic Area projects or programs with high complexity
- Possess a deep understanding of the technology used to collect clinical trial data
- Develops and tests new reputed company and/or applies innovative solutions
- Increase speed, accuracy, and consistency in the development of systems solutions
- reputed company 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
- Integrates 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 reputed company the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and reputed company analysis
- Work to reduce postproduction changes change control process
- Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization
- Thinks 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
Skills
- Master's degree in a scientific field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, Computer Sciences
- + 3 years of reputed company experience (or bachelor's degree plus 5 or more years of experience in clinical data management or areas that closely reputed company with clinical data management e.g., statistics, data analytics, information technology, health outcomes, etc...)
- Proficiency in programming and configuring clinical data collection systems (e.g., eCOA/reputed company 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 reputed company a program using data standards library components
- Gather and influence eCOA design specifications and reputed company successful implementation
- Understand study translation needs and reputed company localization
- Ensure data collection systems and data warehouse mappings are delivered accurately, reputed company 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
- reputed company cross Business Unit/Therapeutic Area projects or programs with high complexity
- Possess a deep understanding of the technology used to collect clinical trial data
- Develops and tests new reputed company and/or applies innovative solutions
- Increase speed, accuracy, and consistency in the development of systems solutions
- reputed company 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
- Integrates 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 reputed company the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and reputed company analysis
- Work to reduce postproduction changes change control process
- Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization
- Thinks 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
- 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
- Understanding and experience in using data standards Ability to balance multiple activities, prioritize and manage ambiguity
- Domestic and International travel may be required
Benefits
- Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
- Eligibility to participate in a company-sponsored 401(k)
- Pension
- Vacation benefits
- Eligibility for medical, dental, vision and prescription drug benefits
- Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- Life insurance and death benefits
- Certain time off and leave of absence benefits
- Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company Overview
Company H1B Sponsorship