Clinical Data Management Coordinator (CDMC) - Fixed Duration Employee

For more than 130 years, Eli Lilly and Company has been dedicated to meeting the health care needs of people in the United States and around the world. We address these needs primarily by developing innovative medicines—investing a higher percentage of our sales in research and development than any other major pharmaceutical company. If you are interested in being considered for employment with a "Best in Class" Pharmaceutical company, please review the following opportunity:

Clinical Data Management Coordinator (CDMC) - Fixed Duration Employee

You will be accountable for ensuring data quality and consistency and meeting timelines for data management deliverables. The CDMC acts as the primary contact within the data management organization for all data management issues for assigned clinical trials. The primary internal customers include Clinical Research Physicians/Clinical Pharmacologists, Statisticians, Pharmacokineticists, and Clinical Operations associates. You will be responsible for providing data management expertise during study development, coordinating the creation of data capture system, enforcing use of data standards, developing study specific strategy for efficient data review, and implementing new technology and processes to increase data management capacity, capabilities, and quality for its customers. The CDMC proactively conducts/coordinates on-going data review throughout the conduct of the study to ensure timely and appropriate identification and correction of errors and discrepancies. The CDMC is responsible for routinely communicating issues to team members and customers. In some cases, some or all of these responsibilities may be delegated to a Third Party Organization (TPO). In these instances, the CDMC is responsible for interacting directly with the TPO, serving in a Projects Management role, overseeing the work of the TPO, ensuring internal customers receive the same deliverables at the same level of quality. This position is not permanent. It is for a fixed duration of up to 4 years.

KEY OBJECTIVES/DELIVERABLES:

Facilitates and/or participates in the Study Development Process. Develops strong business partnerships with Third Party Organizations and provides oversight of the data management deliverables/activities. Understands the relationship between the protocol, case report form, statistical analysis plan, and data review plan. Coordinates design and development of data capture system. Complies with and enforces use of data standards. Coordinates development of data review system. Presents data management materials at start-up meetings as needed. Manages project timelines for data management deliverables. Ensures data consistency across trial subjects and/or sites for assigned trials. Uses appropriate computer-based tools to identify data issues that could impact analysis. Reviews and validates clinical data in accordance with data review plan. Ensures reconciliation of clinical trial database serious adverse events with Lilly Safety System. Works with study team members to identify and resolve data related issues. Communicates project status to study team and supervision. Participates in peer reviews and database quality reviews as appropriate. Defines data lock strategy and coordinates/facilitates the data lock process; accountable for cycle time from Last Patient Visit to data lock. Tracks and reports data management metrics. Understands and maintains documentation on SOP compliance, and where applicable, ensures study deviations/variances are well documented. Ensures data management documents are inspection ready. Accountable for archiving data management study documentation. Suggests and supports process improvements; participates in pilot improvement projects as requested. Provides input for development of policies and procedures. Develops and gives presentations at appropriate team meetings and external forums. Shares best practices, new ideas, lessons learned, and promotes sharing. Builds relationships with people outside of data management to identify opportunities for improving customer service and/or processes. Contributes to the training and development of peers. Understand the confidential nature of company information and take necessary steps to ensure its protection. MINIMUM REQUIREMENTS:
Bachelors degree. Medical and/or Scientific knowledge/expertise. Qualified candidates must be legally authorized to be employed in the United States. Eli Lilly and Company does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. ADDITIONAL SKILLS/PREFERENCES:
Degree preferably in a health-related, scientific, or computer science area. Expertise in MS Access, Visual Basic, statistical methodology. Proven capacity to understand comprehensive data review principles and demonstrated willingness and ability to quickly learn new technical skills as necessary to the project. Capacity to learn and navigate through different data management systems and tools: Clintrial, Inform, I-Review, SAS, Excel. Proficient in computer technology used in an office environment, e.g. word processing and spreadsheet programs, email, and calendaring. Strong projects management skills. Demonstrated self-management skills, including proven ability to prioritize and manage multiple simultaneous projects effectively. Excellent analytical, critical thinking, and problem-solving skills, including attention to detail and accuracy. Excellent written and verbal communication skills, including ability to communicate effectively with global colleagues. Ability to lead cross-functional team. Strong interpersonal and teamwork skills. Knowledge of the clinical trial process and clinical data management, possibly from prior experience as a Clinical Research Administrator, Study Coordinator, or Research Nurse. 2+ years of clinical trial and/or data management experience. Working knowledge of Good Clinical Practices. **There are several Clinical Data Management Coordinator (CDMC) - Fixed Duration Employee positions available through our career website. To review these opportunities, please visit www.lilly.com/careers -- Job ID #50311925, 50312036, 50312101.

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ELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER


If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=506804-3-873