Eli Lilly

Manager-Submission Data Delivery

Eli Lilly • $65K — $148K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree required.
  • Experience in clinical data management or drug development preferred.
  • Knowledge of clinical programming processes and technology.
  • Familiarity with RIM, eCTD, and SAS/R skills.
  • Understanding of global regulatory requirements (e.g., ICH, GCP).

Responsibilities

  • Support project coordination of submissions and data deliverables.
  • Ensure high-quality submission deliverables by leveraging data expertise.
  • Identify and communicate customer needs related to processes and technology.
  • Conduct monitoring and testing for deliverable quality.
  • Build effective business partnerships across teams and functions.
  • Track process metrics and conduct root cause analysis for audits.
  • Implement process improvements to enhance efficiency and reduce cycle time.

Benefits

  • Eligibility for company-sponsored 401(k) and pension.
  • Comprehensive vacation benefits.
  • Medical, dental, vision, and prescription drug coverage.
  • Flexible spending accounts for healthcare and dependent care.
  • Well-being programs including employee assistance and fitness benefits.
Full Job Description
Responsibilities: The Statistics, Data, and Analytics (SDnA) department is responsible for
  • Portfolio - Support the portfolio by enabling delivery of observed and analysis data at the study along with delivery of data sets, Integrated Data Bases and submission deliverables.
  • People - Providing solution consultation to support Statistics, Data, and Analytics (SDnA) processes using process, technology, standards, vendor management, data and regulatory expertise/knowledge, e.g. eSource, CFR 21 Part 11, guidance documents.


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.
  • Submission Data Delivery (70%)
  • This role will include overall project coordination of submissions and coordinate planning of submission data deliverables to ensure the development aligns with the compound's data strategy for the submission (i.e.(Data Definition Documents, XPTs).
  • This role will leverage data expertise to ensure high-quality submission deliverables and stay updated on regulatory guidance in collaboration with other Lilly submission teams.
  • Proactively identify, monitor and communicate customer needs/requirements related to process and/or technology performance and enhancements.
  • Conduct monitoring and testing to ensure deliverable quality in the focus area.
  • Adhere to best practices and global standardized business processes, as applicable to focus area.
  • Process Management & Communication (15%)
  • Build and maintain effective business partnerships with teams, functions, affiliates, and TPOs.
  • Track & maintain process metrics.
  • Provide root cause analysis as needed for process audits and assessments.
  • Process Improvement (10%)
  • Continually seek and implement means of improving processes to reduce cycle time and decrease work effort.
  • Represent SDnA and/or Global PK/PD processes in multi-functional initiatives.
  • Actively engage in shared learning across Statistics, Data, and Analytics.
  • Work with partners to increase vendor/partner efficiencies.
  • Proactively identifies ways to improve day-to-day activities and practices. Support efforts to improve productivity, efficiency, product quality and reduction of risk.
  • Asset Protection (5%)
  • Understand the confidential nature of company information and takes necessary steps to ensure its protection. This includes understanding various aspects of Privacy as it relates to the data managed within Statistics, Data, and Analytics.
  • Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to CROs or other outside parties.
  • Accept obligation to Lilly for compliance to the integrity of the company.
  • Complete readings of any policy/procedure updates including global medical, SDnA, and local policies and procedures.


Basic Qualifications/Requirements
  • Bachelor's degree
  • Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Other Information/Additional Preferences
  • Experience in clinical data management and/or drug development in areas intersecting with clinical data management (e.g. clinical operations, statistics, information technology, health outcomes, pharmacokinetics/pharmacodynamics, etc.) is highly preferred
  • Demonstrated knowledge of clinical programming processes and technology.
  • Experience with RIM, eCTD
  • Demonstrated ability to understand and apply data flow, data quality, data interchange, data standards, and data representation principles.
  • Solid understanding of global internal, external and regulatory requirements/expectations (CCS, ICH, GCP, PhRMA, CSUCI etc.)
  • SAS/R skills and other programming/statistical languages.
  • Knowledge of CDISC format standards (SDTM, ADaM) and data standards
  • Effective written and verbal communication skills in multi-cultural settings
  • High learning agility, initiative, is flexible and has a positive demeanor
  • Good interpersonal and leadership skills.
  • Interpersonal/teamwork and communication skills for effective customer consultation.
  • Strong business acumen.
  • Demonstrated strength in logical thought, problem solving ability and critical thinking.
  • Demonstrated ability to communicate and influence across SDnA, Global PK/PD, CDDA, Regulatory, TPO's, other functional business partners and with external industry forums.
  • Domestic and International travel may be required.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $148,500

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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