Career Opportunities

Career Opportunities

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by our goal of improving the lives of people living with cancer. We pursue this goal with a tenacity, focus, and commitment to excellence that defines who we are and how we work.

We seek dedicated, passionate, hardworking, intelligent, thoughtful, and authentic individuals who thrive within a collaborative and fast-paced environment and will bring their experiences, unique perspectives and problem-solving skills to the team. In return, we cultivate an environment that rewards and recognizes hard work and provides opportunities for learning and growth as part of a team making a meaningful difference in the lives of patients.

Clinical Data Specialist/Senior Clinical Data Specialist

Location: South San Francisco, CA or Stamford, CT or Remote

Reports To:

Associate Director or Senior Manager, Clinical Data Management

Position Summary

Loxo Oncology at 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 Oncology at 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 Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Data Management Support position is responsible for performing clinical data management tasks from study start-up through eTMF archiving as directed by the study Lead Data Manager (LDM). 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 LDM review. The Data Management Support position ensures all actions are in full compliance with Loxo standard operating procedures (SOP) and regulatory agency guidelines. 

Roles and Responsibilities of the Position*
  • Assists the Sponsor LDM to provide day to day support of Data Management (DM) services, including but not limited to the following tasks.
  • Partners with Contract Research Organization (CRO) DM for tracking and reporting on vendor data completeness and cleanliness.
  • Generates and distributes study data metric reports and data review listings which may include Excel pivot tables, algorithms, or VLOOKUP.
  • May be requested to perform oversight of vendor data including timeline development, PowerPoint slide development and presentation, and data trends reporting.
  • Communicate complex issues clearly through multiple media methods including email, instant message, text, telephone, and video phone.
  • May develop low-complexity data listings from Electronic Data Capture (EDC), JReview, or other reporting tool.
  • Drafts specifications for medium to high-complexity listings and reports.
  • Performs data review as directed by the LDM.
  • Vendor data transfer management
  • Drafts Sponsor DM documents such as Data Transfer Specifications (DTS), Data Management Plan (DMP), EDC design specifications, edit check specifications (ECS), Data Snapshot Requirements Plan, et al.
  • Performs Sponsor DM review of CRO generated Data Management documents such as:  CRF completion guidelines, DMP, data reconciliation plans, ECS or any other document as assigned by the LDM.
  • Performs Sponsor user acceptance testing (UAT) of EDC, reports, listings, data integrations, et al.
  • Works in partnership with CRO and DM Vendor representatives to ensure DM services timelines are transparent and on-track.
  • Attends internal, vendor, and CRO meetings as directed by the LDM.
  • Performs any and all other tasks and activities as requested.
Required Qualifications and Background
  • Bachelor’s degree in life sciences, math, computer science or related field required.
  • Minimum of two years’ clinical data management experience. 
  • Oncology research experience is preferred.
  • Proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
  • Experience in MS Project is preferred.
  • Experience with web-based 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.
  • Available to assist the study team to achieve important data deliverables across Pacific and Eastern Time Zone.
  • Self-driven and high achieving while maintaining a focus on quality in all aspects of work.
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 infrequent (<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 the employee’s home office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility 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.

For more information about Loxo Oncology’s privacy practice, please view the Privacy Statement.