Eli Lilly and Company
Clinical Study Build Programmer - eCOA
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
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 requires an in-depth understanding of data technology, data flow, data standards, database programming, normalization, and testing. The Clinical Study Build Programmer will 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
Gather and influence eCOA design specifications and enable successful 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 Understand study translation needs and enable localization 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 Possess a deep understanding of the technology used to collect clinical trial data Develop and test new ideas and/or apply 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 postproduction 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 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 Work to reduce postproduction changes change control process 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 of external developments, timelines Focus on defining database solutions and timelines in support of advancing the portfolio Minimum Qualification Requirements:
Master’s degree plus a minimum 3 years’ experience (or bachelor’s degree with a minimum 7 years’ experience) with clinical database programming in a pharmaceutical, biotech, CRO, or regulatory agency setting Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position Additional Preferences:
Experience with designing and handling of eCOA data 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 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 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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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 requires an in-depth understanding of data technology, data flow, data standards, database programming, normalization, and testing. The Clinical Study Build Programmer will 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
Gather and influence eCOA design specifications and enable successful 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 Understand study translation needs and enable localization 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 Possess a deep understanding of the technology used to collect clinical trial data Develop and test new ideas and/or apply 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 postproduction 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 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 Work to reduce postproduction changes change control process 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 of external developments, timelines Focus on defining database solutions and timelines in support of advancing the portfolio Minimum Qualification Requirements:
Master’s degree plus a minimum 3 years’ experience (or bachelor’s degree with a minimum 7 years’ experience) with clinical database programming in a pharmaceutical, biotech, CRO, or regulatory agency setting Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position Additional Preferences:
Experience with designing and handling of eCOA data 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 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 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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