eCOA Study Designer

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 39,000 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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the global by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
 

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:
 

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 (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

• 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:

• Bachelor’s degree with 3 or more years of experience in database programming, clinical data management or system validation experience in the clinical, pharmaceutical, biotech, CRO or regulatory agency sectors

Additional Preferences:

• 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

Experience with the following:

• eCOA, eSource or Direct Data Capture implementation

• 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 (i.e. Data Sciences, Statistics, PK, Operations, Medical)

• Strong therapeutic/scientific knowledge in the field of research

• Society of Clinical Data Management certification

• Project management experience

• Vendor management experience

• Familiarity with clinical data tools and technologies

• 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 Information:

• Domestic and International travel may be required

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.