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Consultant Data Standards

Eli Lilly and Company

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Location: Indianapolis, IN Posted Date: 4/16/2013 Position Type: Full time Job Code: ELY2094BRBS Required Education: Bachelors Degree Areas of Expertise Desired: Information Systems

Description

Responsibilities
The Clinical Data Flow and Technology (CDFT) department within Biometrics and Advanced Analytics is responsible for:
•   Standards – Influence, define, and instantiate core and therapeutic area standards for broader reusability and drive toward consistency; understand, influence, and incorporate industry standards (CDASH, SDTM, ADaM, ODM).
•   CDF Technologies and Process – Define, Implement and Manage the processes and technologies, (i.e., InForm, CIS, ClinTrial, Integrations, SDD, CDI, and niche statistical software) to support the Clinical Data Flow from data collection through analysis/integrated databases/submission deliverables.
•   Portfolio – Support the portfolio by enabling delivery of observed and analysis data at the study along with delivery of PK data sets, Integrated Data Bases and submission deliverables.
•   People - Providing solution consultation to support CDF processes utilizing process, technology, standards, vendor management, data and regulatory expertise/knowledge, e.g. eSource, 21 CFR Part 11, guidance documents.

The Consultant Data Standards is responsible for providing technical leadership and ownership for data standards across the clinical trial dataflow. The main responsibilities of this role are:
•   Developing standards to be used and followed at each stage of the clinical trial dataflow.
•   Maintaining libraries of clinical trial data standards accessible to all Lilly personnel.
•   Ensuring facility of data transfer between Lilly and external partners by defining relationships between internal and external standards.
•   Developing metadata used to control and automate the clinical trial dataflow process.

Specific Focus Area:
•   Provide leadership in standards development (eg., DED/CDASH, CRF, SDTM, ADaM and TFL) across Lilly.
•   Administration of Standards Governance Architecture overall at Lilly.
•   Organize, host and document/drive discussions to decisions at Standards Control Board (SCB) meetings.
•   Prepare agenda, create, assign, and track/drive SCB action items to completion within agreed upon timelines.
•   Monitoring the request system for requests for SCB review.
•   Maintain document center (core standards), document and communicate SCB meeting decisions.
•   Define, implement, track standards compliance and metrics across Lilly; influence uptake of standards and report back on the value achieved to Standards Advisor, Mgmt.
•   Coordinate and host therapeutic area standards team (TAST) meetings.
•   Provide standards guidance and connection back to SCB for TAST.
•   Provide quality review of new request for standards and ensure requests are appropriately triaged and developer/owners are assigned and track/drive through completion.

KEY RESPONSIBILITIES OF JOB
Data Standards Development and Maintenance (60%)
•   Develop standards for collected data elements (e.g. terminology)
•   Develop standards to be used in data collection systems including CRFs, edits, and source data
•   Develop standards for transformations of source data into Analysis Data Sets and Submission Data Sets, including derived variable standards
•   Develop metadata used to automate and control the clinical trial dataflow process
•   Maintain standards compliant library components (i.e. forms, panels, rules, derivations).
•   Influence the organization to adopt standards and ensuring that standards are created in a timely way

Deliverable Ownership (15%)
•   Define data deliverables and ensure their successful delivery by execution resources

External Influence (10%)
•   Engagement with external data standards organizations (i.e. CDISC) Participation on external committees to develop and influence industry standards • Understand data standards external to Lilly (e.g. CDISC) and facilitate mapping between internal and external data standards for both submission and when dealing with vendors and other third parties

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.

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.

Requirements

Basic Qualifications
•   Bachelor’s degree preferably in Medical Informatics, Information Technology or Statistics or equivalent Lilly experience in data standards development or implementation.
•   Minimum of 2 years experience in clinical data management, data standards, IT or Statistics or 3 years experience in drug development in areas intersecting with clinical data management (e.g. clinical operations, health outcomes, etc.) Technical aptitude in the area of data standards.

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
•   Ability to articulate the flow of data (content, structure and format) from patient to analysis and apply this knowledge to data standard development.
•   Familiarity with clinical data standards tools and technologies. Demonstrated programming knowledge and ability to apply knowledge to the development of standards and/or project deliverable.
•   Familiarity and experience with industry data standards (e.g. SDTM, ODM, ADaM, HL7 etc)
•   Project management skills Familiarity with SQL, ORACLE, XML Vendor management/oversight skills
•   Have experience in standards development, and influence, drive and organize cross functional representatives providing input to standards development

ELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER
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