Senior Associate Library Management
Eli Lilly - Indianapolis, IN

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The Data Sciences and Solutions department within the Clinical Development Organization (CDO) is responsible for global consistency of medical data; structure, content and meaning, acquisition, storage, retrieval, interchange and representation. This requires an in depth understanding of data collection, data flow management, data quality, data technology, data archiving and data standards. The Associate/Sr. Associate/Associate Consultant - Library Management is responsible for providing technical leadership, oversight and ownership for the delivery and support of standard compliant components needed across the clinical trial dataflow:

  • Oversee the requirements gathering, creation and testing of the library components Influence creation of new standards when needed
  • Collaborate with third party organization to support clinical trial dataflow process Integrate emerging external standards that impact the clinical trial dataflow process
  • Utilize metadata to optimize data flow
KEY OBJECTIVES/DELIVERABLES:
1. Library Component Creation and Management (60%)

  • Oversee the requirements gathering, creation and testing of the library components
  • Create and maintain standards compliant library components Influence creation of new standards when needed
2. Deliverable Ownership (25%)

  • Define data deliverables and ensure their successful delivery by execution resources
3. Process Improvement (10%)

  • Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
  • Represent Data Sciences processes in cross-functional initiatives Actively participate in shared learning across Data Sciences and Solutions
  • Work with partners to increase vendor/partner efficiencies
4. Asset Protection (5%)

  • Understand the confidential nature of company information and takes necessary steps to ensure its protection
  • This includes understanding various aspects of Privacy as it relates to the data managed within Data Sciences and Solutions
  • Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to CROs or other outside parties
  • Accept obligation to Lilly for compliance to the integrity of the company
  • Complete readings of any policy/procedure updates including global medical, Data Sciences and Solutions, and local policies and procedures
MINIMUM REQUIREMENTS:
  • Bachelors degree
  • Minimum of 3 years experience in clinical data management, IT, or Statistics and/or 5 years experience in drug development in areas intersecting with Data Sciences & Solutions (e.g., Clinical Operations, Health Outcomes, etc.)
  • Strong clinical knowledge and an ability to liaise effectively with customers
  • Strong database, technology, and information systems knowledge
  • Demonstrated ability to prioritize work effectively
  • Ability to articulate the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions
  • Demonstrated programming knowledge and/or ability to apply systems knowledge to the development of Library requirements and/or deliverables (i.e. Oracle, XML)
  • Familiarity with Data Sciences Library tools and technologies
  • Knowledge of Corporate Computer Systems processes
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/ Preferences:
  • Proven project management skills Strong interpersonal and leadership skills
  • Excellent oral and written communication skills
  • Experience in forms design and layout preferred
  • Familiarity with clinical data tools and technologies
  • Ability to work in a virtual team environment, with outsourced partners, etc.
  • Knowledge of medical terminology
  • Proven vendor management skillsOtherBachelor's DegreeFull-Time
Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. A company rich in heritage, Lilly employs individuals, conducts research and markets products worldwide. By providing for the unmet needs of our customers through a continuous stream of innovation, we will outgrow all competitors.

Lilly earns consistent and wide recognition for creating an exceptional work environment while maintaining our highly regarded reputation in the Pharmaceutical Industry and Community. The following is a selection of awards and recognition Lilly has received in recent years:

Awards and Recognition

ELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY

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Eli Lilly and Company discovers, develops, manufactures and sells products in one business segment, pharmaceutical products. The Company...