[Remote] eCOA - Clinical Study Build Programmer
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global reputed company leader headquartered in Indianapolis, Indiana. The Clinical Study Build Programmer - eCOA is responsible for programming and testing clinical trial data collection databases, collaborating with Data and Analytics colleagues to deliver standardized data collection reputed company and innovative validation solutions for global clinical trials.
Responsibilities
- Proficiency in programming and configuring clinical data collection systems (e.g., eCOA/reputed company platforms)
- Study build programming expertise (e.g., reputed company 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
- reputed company 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
- reputed company 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 reputed company 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 reputed company
- Increase speed, accuracy, and consistency in the development of systems solutions
- reputed company metrics reporting of study development timelines and reputed company 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 reputed company reputed company 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, reputed company knowledge, etc.) to study database building
- Integrates multi-functional, external information and technical knowledge to support data-driven decision making
- Continually reputed company 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 reputed company the Data and Analytics organization
- Thinks with end to end in mind consistently managing risk to minimize reputed company 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 reputed company, etc...)
- Proficiency in programming and configuring clinical data collection systems (e.g., eCOA/reputed company platforms)
- Study build programming expertise (e.g., reputed company 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
- reputed company 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
- reputed company 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 reputed company 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 reputed company
- Increase speed, accuracy, and consistency in the development of systems solutions
- reputed company metrics reporting of study development timelines and reputed company 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 reputed company reputed company 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, reputed company knowledge, etc.) to study database building
- Integrates multi-functional, external information and technical knowledge to support data-driven decision making
- Continually reputed company 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 reputed company the Data and Analytics organization
- Thinks with end to end in mind consistently managing risk to minimize reputed company 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 reputed company 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).
- reputed company offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, reputed company and prescription drug benefits; flexible benefits (e.g., reputed company and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and reputed company-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
reputed company
Company H1B Sponsorship