Data Quality Oversight 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 35,000 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.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Core Responsibilities
- Prioritize work based on strategy and communicate and coordinate resulting decisions with cross-functional leaders
- Build and leverage relationships with Process Owners, Product Owners/and or SMEs, Clinical Capabilities Functional Leads, quality, and IT in order to ensure understanding, agreement and alignment on the expectations relative to data quality oversight in clinical systems
- Accountable for identifying, reporting and following-up on inconsistent data or data errors within the clinical systems. Communicate directly with functions and document gaps in data entry required across the clinical platform
- Create metrics and dashboards for clinical systems to identify inconsistencies and missing data
- Identify, communicate, and resolve issues
- Perform departmental tasks, including being a technical expert or overseeing projects
- Partner with product/process owner group for system upgrade and validation
- Support in dashboard creation with collaboration with internal team

Project Management
- Manage regular data quality metrics reporting, communication and issue resolution in a timely manner.
- Develop cross functional and system communication plans with stakeholders
- Understand, comply, and reinforce local regulations and guidance, Lilly medical policies and procedures, and good clinical practices (GCP)
- Understand business strategies, processes, and technology as it relates to the expectations of data quality across clinical systems
- Work to develop best practices, process improvements

TMF Expertise
- Partner with internal colleagues to develop and execute metrics to demonstrate control of the TMF process.
- Support internal audits and external inspections, as appropriate (e.g. a table of contents based on the trial-specific TMF Expected Document Lists (EDLs).
- Assists TMF operation hub group with providing process and planning support with TMF related remediation and process execution as needed.
- Handles eTMF technical process related questions and answers.
- Provide support with TMF Operations administrative activities such as TMF open office hours, meetings agendas/minutes, etc.
- Provide support to ongoing and ad-hoc TMF projects, initiatives and activities, as needed
- Provide ad-hoc support to perform quality check of eTMF documents as per the ALCOA+++ guideline and liaise with project teams to resolve any issues identified, as needed
- Evaluate and tailor the expected documents (ED) to ensure proper tailoring has been assessed to make a trial specific TMF.
- Evaluate the TMF records prior to finalization, as appropriate.

Minimum Qualification Requirements:

- 3-8 years’ experience with clinical system development processes
- A bachelor’s degree or equivalent preferably in a scientific, health related field or technology.
- Strong networking, interpersonal and relationship skills, with demonstrated ability to work in teams and across organizational boundaries
- Detailed oriented, strong written and verbal communication skills, highly proficient with MS Office/Adobe Acrobat
- Experience in working with electronic trial master files and/or data analytical field strongly preferred
- Demonstrated critical thinking capabilities with forward looking perspective and comfort with ambiguity
- Clinical research experience or relevant experience preferred
- Effective communication, teamwork, and problem-solving skills
- Very good attention to details and accuracy

Other Information/Additional Preferences:

- Applied knowledge of project management processes and skills
- Appreciation of / experience in compliance-driven environment
- Ability to learn and comply with regulatory requirements and internal policies.
- Self-management and organizational skills
- Excellent computer skills
- Language Capabilities - English (read, write, conversation) and local language, as applicable

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gend