Loxo@Lilly Manager/Senior Manager, Laboratory Data in Harrisburg, Pennsylvania
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 Manager/Sr. Manager, Laboratory, is responsible for the quality of lab data that begins prior to study start-up and continues through eTMF archiving as it relates to the lab review and management of clinical lab data. This position will be accountable to lead and implement process development activities as it relates to clinical lab data. In addition, the role will work with the study Lead Data Manager and core team during start-up, execution and through all delivery milestones as needed to support the lab data. The Manager/Sr. Manager, Laboratory, ensures all Data Management activities stay within full compliance of Loxo regulatory and legal policies.
Roles and Responsibilities of the Position:
Evaluate and design DM processes for lab data flow
Evaluate and design DM processes for quality control of lab data
Coordination with study Core Team to ensure lab data flow and process is consistent with delivery needs for end point analysis
Monitors the progress of all data management activities in correlation to the lab needs on all studies to ensure project timelines are met.
Provides day to day support of overseeing the quality review and reconciliation of safety and efficacy laboratory data.
Provides oversight and support of the local lab reference range management process.
Proactively identifies potential program and delivery issues/risks with lab data and recommends/ implements solutions.
Collaborate with Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
Attends internal, vendor and CRO meetings as directed.
Performs all other tasks and activities as requested by program lead and data management leadership.
Required Qualifications and Preferred Background:
Bachelor’s degree in life sciences, math, computer science or related field required. Master’s degree in life sciences, math, computer science or related field preferred.
Minimum of 5 years’ clinical data management experience.
Knowledge of lab reconciliation process.
Demonstrated leadership, line management and project management skills.
Oncology/Hematology experience strongly preferred.
Thorough and broad knowledge of data management processes.
Must have excellent verbal, written and communication skills.
Proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
Experience in MS Project is preferred.
Experience with web-based Electronic Data Capture (EDC) and 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.
Available to assist the study team to achieve important data deliverables across all North American time zones.
Self-driven and high achieving while maintaining a focus on quality in all aspects of work.
Ability to work independently as well as in a team environment.
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Manager level position could range from between $103,200 to $151,423 and that the base salary for the Senior Manager level positions could range between $118,700 to $174,137 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.
Additional Locations for this role:
South San Francisco, CA
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 5-10% 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 an 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 Oncology, Inc. 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 Oncology, Inc. (“Loxo”) 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 firstname.lastname@example.org 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.