Loxo@Lilly Senior Associate/Manager, Clinical Application Programmer in Augusta, Maine
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.
The Clinical Application Programme r is responsible for configuration and script writing for in-house clinical database builds for studies conducted by Loxo@Lilly, while maintaining a high degree of quality in all work performed. This role ensures all assigned database builds are appropriately tracked, resourced, and budgeted for successful completion, and ensures the project status is transparently disseminated throughout the organization. They maintain effective working relationships at all levels within and outside of Loxo@Lilly.
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. A general understanding of the requirements for GxP systems implementation and maintaining systems in a validated state, is a plus. The individual will be a self-starter with excellent leadership skills, strong focus on innovation, collaboration, and most importantly, application programming and tools.
*Roles and Responsibilities of the Position:
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.
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.
Contribute to the quality of the data management clinical database programming deliverables including specification development, eCRF development, edit checks programming, and Quality Testing.
Expertise in the development, support, and optimal use of the CRF library collections (Veeva CDMS, et al) and other data environments.
Ability to support business initiatives along with being an advocate for business stakeholders to various system owners
Proactively identifies potential technical and operational issues/risks and recommends/ implements solutions.
Engage in the governance and management of the CRF Library Standards; maintain and support Library documentation.
Establish and implement programming standards and comply with regulatory requirements.
Participate in the development of, and ensure compliance to, standard operating procedures (SOPs), policies, guidelines, and programming standards.
Perform all other tasks and activities as requested
Required Qualifications and Preferred Background:
Bachelor’s degree preferred.
Minimum of 3 years’ experience in electronic data collection application programming within life sciences.
Minimum 2 years’ oncology experience, preferred.
Expertise in Clinical Programming, methods, and techniques
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
Ability to work independently as well as in a team environment.
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 currently anticipates that the base salary for the Senior Associate position level could range from between $75,000 to $110,000 and that the base salary for the Manager position level could range from $90,000 to $132,000 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items. The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.
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 be met by an employee to successfully perform the essential functions of this job.
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 while performing 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.
Loxo@Lilly (Eli Lilly and Company) 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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
Loxo@Lilly (Eli Lilly and Company) is committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process for positions at Loxo, please email email@example.com for further assistance. Please note, this email address is intended for use to request an accommodation as a part of the application process. Any other correspondence will not receive a response.