Manager - Clinical Data Management

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Summary:

The Manager, Data Management will be responsible for overseeing data management tasks from study start-up through database lock for clinical trials. This individual collaborates with the Clinical Operations and Biostatistics teams as well as 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

Responsibilities:

• Represents data management in study team meetings.
• 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.
• Oversight of data management CRO/service providers on assigned studies.
• Monitors the progress of all data management activities on assigned studies to ensure project timelines are met.
• 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, able to work independently towards the assigned goal.
• Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.

Basic Requirements:

• Bachelor’s degree in Life Sciences, Computer Sciences, Mathematics, health related field or equivalent experience required.
• 3+ years of CDM experience in the pharmaceutical or biotechnology industry required.
• Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements.
• 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
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines
• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)
• Knowledge of industry standards (CDISC, SDTM, CDASH)
• Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
• Proven ability to work both independently and in a team setting.

Additional Preferences:

• CRO management experience a plus
• Prior oncology/hematology experience highly desirable

Additional Information:

Physical Demands/Travel:

The physical demands of this job are consistent with an office/remote office environment.

 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 an office setting.

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

Lilly currently anticipates that the base salary for this position could range from between $63,000 to $92,400 and will depend, in part, on the successful candidate’s qualifications for the role, including educatio