Clinical Data Associate

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 eDC Clinical Study Build Programmer 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.

This role will collaborate with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Manager and other key partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials.

** Responsibilities:*
* ** Portfolio Delivery:*
* + 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

+ 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

+ Apply 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 the organization

+ Work to Increase re-usability of forms 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

** Other responsibilities*
* + The experienced Clinical Study Build Programmer - eDC is expected to provide coaching and guidance for junior Clinical Study Build Programmers.

+ The Clinical Study Build Programmer - eDC may or may not lead a team of junior Clinical Study Build Programmers. If in supervisory positions, the Clinical Study Build Programmer - eDC is expected to:

+ Participate in the recruitment, development, and retention of a scientific, technical, and operationally capable workforce that is skilled and knowledgeable in end-to-end global clinical eDC system builds

+ Provide effective technical leadership to an agile team of technical staff that continuously meets the needs of a changing portfolio and demonstrates judgment-based decision making, and provide leadership in clinical eDC system build delivery

+ Creating a team culture that fosters inclusion and innovation and values diversity

+ Responsible for effective resource planning

+ Responsible for supervising clinical study build programmer staff, as assigned, including aspects of training, mentoring, goal setting, performance management, and engagement. Other…