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.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe 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.
Position Summary:
The Associate is responsible for performing clinical data management tasks from study start-up through eTMF archiving as directed by the study Lead Data Manager. This individual collaborates with the cross- functional study team to develop Sponsor clinical data review listings, perform Sponsor Data Manager data review/cleaning, post, and QC data transfers to and from Loxo, generate and report on study data metrics, and draft the Sponsor Data Management Plans for Lead Data Manager review. The Associate ensures all actions are in full compliance with Loxo standard operating procedures (SOP) and regulatory agency guidelines.
Responsibilities:
- Represents data management in study team meetings.
- Executes and/or distributes data management metrics, listings, and reports, as required for study team review.
- Performs routine and critical data review as specified in the study Data Management documents.
- Generates and/or reviews/approves Data Management study documents such as: CRF completion guidelines, data management plan (DMP), data transfer specifications, SAE and/or external data reconciliation plans, edit check specifications (ECS).
- Perform Sponsor user acceptance testing (UAT) of electronic data capture (EDC) database, edit checks, reports and listings, and interactive X response systems (IxRS) as needed.
- Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
- Proactively identifies potential study issues/risks and recommends/implements solutions.
- Performs any, and all, other tasks and activities as requested.
Basic Requirements :
- Bachelor’s degree in life sciences, math, computer science or related field required.
- Minimum of 3-6+ years’ clinical data management experience.
Additional Preferences:
- Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
- Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
- Demonstrated proficiency in executing independent UAT.
- Demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
- Self-driven and high achieving while maintaining a focus on quality in all aspects of work.
- Experience with Veeva EDC is preferred.
- Oncology research experience is preferred.
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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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 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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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