Senior Associate/Manager, Clinical Application Programmer
Company: Loxo@Lilly
Location: Santa Fe
Posted on: January 25, 2023
|
|
Job Description:
Loxo@Lilly conducts discovery research, clinical development and
regulatory affairs for oncology, with the goal of creating a
pipeline of therapies that have the potential to make a meaningful
difference for patients. Loxo@Lilly was created in December 2019,
combining the Lilly Research Laboratories oncology organization and
Loxo Oncology, which was acquired by Lilly in early 2019. The unit
has team members in Louisville, CO, Indianapolis, IN, New York
City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, 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._**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 be met by an employee 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 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_ loxoaccommodation@loxooncology.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._
Keywords: Loxo@Lilly, Santa Fe , Senior Associate/Manager, Clinical Application Programmer, Executive , Santa Fe, New Mexico
Click
here to apply!
|