Sr. Principal - Clinical Study Build Programmer - eDC at Eli Lilly and Company

Indianapolis, Indiana, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Healthcare, Clinical ResearchIndustries

Requirements

In-depth understanding of data technology, data flow, data standards, database programming, normalization and testing
Therapeutic knowledge and deep understanding of technology used to collect clinical trial data
Knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc.)

Responsibilities

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 work (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
Develop and test new ideas and/or apply innovative solutions that add new value to the portfolio
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
Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations to study build work
Integrate multi-functional and/or external information and apply technical knowledge to data-driven decision making
Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable normalization of various sources of data into a common data repository
Represent Data and Analytics processes in multi-functional initiatives
Actively engage in shared learning across the organization
Increase re-usability of forms and edits by improving the initial design
Reduce postproduction changes change control process
Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization
Interact with regulators, business partners and outside team members on business issues
Think with end-to-end in mind consistently managing risk to minimize impact on delivery
Build a diverse multi-functional and internal/external network to understand how different disciplines and approaches contribute to research and development
Focus on defining database solutions and timelines in support of advancing the portfolio

Skills

database programming

data mapping

data normalization

data standards

clinical trial data

eDC

data testing

data warehouse

SQL

CDISC

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

Land your dream remote job 3x faster with AI

Try Jobo Free