Senior Associate - Clinical Study Build Programmer

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.

About Loxo@Lilly:

Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients.  We intend to curate a balanced pipeline of medicines, either internally or externally discovered, with the potential to treat cancer with dramatic effect.  Loxo@Lilly was created in December 2019, combining the Lilly Oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019.  Loxo@Lilly is a global organization with team members in Louisville, Colorado; Indianapolis, Indiana; New York City, New York; San Diego, California; South San Francisco, California; Stamford, Connecticut; and Madrid, Spain.

Position Summary:

The 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. The Clinical Study Build Programmer will collaborate with Data and Analytics colleagues such as the CRF Standards Lead, Clinical Data Manager and other key stakeholders to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials.

The ideal candidate will have varied experience in electronic data collection technologies, such as Veeva EDC, Medidata Rave, and Oracle InForm, etc., as well as a sufficient knowledge of industry clinical data standards, the management of CRF library collections, developing CRFs, dynamics and rules, and the integration of third-party data. project management of study deliverables and milestones.  The individual will be a self-starter with excellent leadership skills, strong focus on innovation, collaboration, and most importantly, application programming and tools as a representative of data and analytics processes across functional initiatives.

Roles and Responsibilities of the Position:

• 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)
• Contribute to the quality of the data management clinical database programming deliverables including specification development, eCRF development, edit checks programming, and Quality Testing.
• Serve as a subject matter expert in the use of EDC platforms and their suite of products including Studio/Designer, EDC, Local Lab Module, Coder, Data Extract and Reporting, among others. 
• 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 with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Management Associate to deliver study database per business need and before first patient visit
• Comply with and influence data standard decisions and strategies for a study and/or program
• Provide oversight, technical support, and guidance to the study teams in the efficient use of the EDC product suite in the study planning, execution, and close out activities of clinical studies.
• Proactively identifies potential technical and operational issues/risks and recommends/ implements solutions.
• Perform all other tasks and activities as requested.

Qualifications and Background:

Required:

•  Bachelor’s degree preferred.
• Minimum 3 years’ experience in clinical data management, database programming or system validation experience in the clinical, pharmaceutical, biotech, CRO or regulatory agency sectors.
• Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.
• Knowledge of industry standard clinical technologies including CTMS, EDC (Veeva CDMS preferred, Rave, InForm), eCOA, IxRS, Clinical Data Repositories, etc.
• Knowledge of CDISC and CDASH standards/standard terminology

Ideal candidate will also have:

• Ability to work independently as well as in a team environment.
• Minimum 2 years’ oncology experience preferred.
• Project and Vendor management experience
• Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
• Demonstrated ability to stay abreast of trends and new information in the profession.

Loxo@Lilly (Eli Lilly and Company) currently anticipates that the base salary for this position could range from between $63,000-92,400 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Loxo@Lilly (Eli Lilly and Company)  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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo@Lilly (Eli Lilly and Company) reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Loxo@Lilly (Eli Lilly and Company) compensation practices and guidelines will apply regarding the details of any promotion or transfer of Loxo@Lilly (Eli Lilly and Company) employees.

Physical Demands/Travel:

The physical demands of this job are consistent with light office duties. This position will travel occasionally; the average travel for this position is 10% with some variation based upon the demands of the business imperatives.

The physical demands here are representative of those that must bemet by anemployee to successfully perform the essential functions of this job.

Work Environment:

This position’s work environment is in a home-based office setting.

The work environment characteristics described here are representative of those an employee encounters whileperforming the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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