Job description
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.
The Senior Associate, Data Management Consultant is responsible for performing clinical data management tasks from study start-up through eTMF archiving as directed by the study Lead Data Manager. This individual collaborates with the cross-functional study team to develop sponsor clinical data review listings, perform Sponsor Data Manager data review/cleaning, post and QC data transfers to and from Loxo, generate and report on study data metrics, and draft the Sponsor Data Management Plans for review. This individual will also ensure all actions are in full compliance with Loxo standard operating procedures (SOP) and regulatory agency guidelines.
Roles and Responsibilities of the Position:
- Generates data metric reports and listings for study team review.
- Performs routine and critical data review as specified in the study Data Management documents.
- Performs review of Data Management documents such as: CRF completion guidelines, data management plan (DMP), data reconciliation plans, edit check specifications (ECS).
- Perform Sponsor user acceptance testing (UAT) of electronic data capture (EDC) database, edit checks, reports and listings, and interactive X response systems (IxRS) as needed.
- Performs any, and all, other tasks and activities as requested.
Required Qualifications and Preferred Background:
- Bachelor’s degree in life sciences, math, computer science or related field required.
- Minimum of 2 – 5 years’ clinical data management experience required.
- Demonstrated proficiency in executing independent UAT.
- Demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
- Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug. Experience with Veeva EDC is preferred.
- Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
- Oncology research experience is preferred.
- Self-driven and high achieving while maintaining a focus on quality in all aspects of work.
Available Locations for this role:
- Remote- US Based
- South San Francisco, CA
- Stamford, CT
Physical Demands/Travel:
The physical demands of this job are consistent with light office duties
.
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 the employee’s home office.
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.
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.
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