Career Opportunities

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Reports To:

Associate Director/Director, 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 Lead Clinical Data Manager is responsible for leading and overseeing data management tasks from study start-up through database lock for clinical trials.  This individual works collaboratively across multiple cross functional groups including Clinical Trial Managers (CTM’s), Biostatistics and Clinical Data Management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines. The Lead Clinical Data Manager ensures all Clinical Operations activities stay within full compliance of Loxo standard operating procedures (SOP) and regulatory agency guidelines.

Roles and Responsibilities of the Position*

• Represents Clinical Data Management at study team meetings with responsibility for operational execution of CDM activities
• Executes and manages data management timelines to coordinate and synchronize deliverables with the overall study timelines
• Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols, UAT execution)
• Executes and/or distributes data management metrics, listings, and reports, as required
• Escalate resource need to PL to meet the current study needs
• Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc) to data collection and DM plans
• Collaborate and oversee CRO/service providers on assigned studies
• Executes/manages all data management activities on assigned studies to ensure project timelines are met
• Continually seek means of improving processes to reduce cycle time and decrease work effort
• Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed
• Proactively identifies potential study issues/risks and recommends/ implements solutions
• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial for all data deliverables
• Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables
• Work with partners to increase vendor/partner efficiencies
• 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 6+ years’ clinical data management experience. 
• Demonstrated leadership and project management skills.
• Thorough and broad knowledge of data management processes, including EDC and interactive voice response system (IVRS)experience.
• Demonstrated proficiency in MS Office (Outlook, MS 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.
• Good working knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.
• Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH).
• Excellent verbal, written and interpersonal skills required for working successfully in a cross-functional team environment.
• Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone and by email.
• Proven 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.
• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
• Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email

Additional Preferred Qualifications

• 5+ years prior oncology/hematology experience highly desirable
• 2+ years prior sponsor experience preferred.
• Recent Phase 3 registration study and submission experience preferred

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 15-20% 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 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.

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