Clinical Data Associate Process/Technology-Fixed Duration Employee

Employer
Lilly
Location
Indianapolis
Salary
Competitive
Posted
June 16 2017
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Pharma
Job Type
Other
Responsibilities
The Data Sciences and Solutions department 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 Process and Technology role is responsible for providing technical leadership and process ownership for Data Sciences and Solutions. These are the broad applications/focus areas for this role:
  • Apply specialized process/technology knowledge to ensure clinical trial deliverables are consistent and accurate
  • Act as a primary contact within the Data Sciences and Solutions organization for development and support of process and technology
  • Communicate and adhere to the global data strategy across the organization as it relates to process and technology
Focus area: Subject matter expertise in Oracle Central Designer and InForm systems to support clinical trial design, build and execution across the portfolio of assets; serve as technical expert to assist teams with trouble shooting, business process recommendations and oversight of implementation and use of Central Designer and InForm; manage system outages and upgrades; communicate and partner with clinical study teams to deliver the portfolio and meet customer needs.

Process/Technology Strategy Support (40%)
  • Define, deliver, and continuously improve global processes and/or technology to facilitate the reliable planning and execution of deliverables
  • Assist during the design and execution of clinical trials to ensure the development of the trial is consistent with the global data strategy, as applicable to focus area
  • Identify, monitor and communicate global customer needs/requirements related to process and/or technology performance and enhancements
  • Ensure process and/or technology interfaces are optimized across Biometrics and Advanced Analytics
  • Provide business case analysis as needed for Biometrics and Advanced Analytics initiatives, as applicable to focus area
  • Support the identification, communication, maturation and adoption of best practices and global standardized business processes, as applicable to focus area.
  • Marry deep phase/TA/geography expertise with deep process and/or technology expertise, as applicable to focus area.
  • Manage projects/process/technology that span across multiple functions/vendors/other external organizations, areas of focus are InForm/CIS/Central Designer, Clintrial Integrations and CTMM Integrations, Submissions, Integrated Databases, MedDRA/WhoDRUG/SAE in InForm/LSS and other systems.
  • Partner and/or strengthen relationships between key providers or customers, including influencing statisticians, statistics COE, physicians, clinical pharmacology and clinical operations etc, as applicable to focus area.
  • Define, measure and achieve group proficiency with new tools/technology, processes, and the application of best practices as applicable to focus area.

Business Office Support (40%)
  • Partner with LRL Financial and Procurement to manage budgets, invoice processing and payments, work orders and contracts
  • Provide guidance and consulting into forecasting expenses
  • Develop, track and maintain business office metrics
  • Build and maintain effective business partnership with teams, functions and affiliates understanding needs and ensuring timely response
  • Define and provide guidance related to vendor management
  • Provide business case analysis as needed for Biometrics and Advanced Analytics initiatives

Process Improvement (15%)
  • 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 Clinical Data Flow and Technology
  • 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 Clinical Data Flow and Technology.
  • 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, Clinical Data Flow and Technology, and local policies and procedures

Note: Incumbent may do a blend of items #1 & #2.


Basic Qualifications
  • Bachelor's degree
  • Minimum 3 years experience in clinical data management and/or 5 years experience in drug development in areas intersecting with clinical data management (e.g. clinical operations, statistics, information technology, health outcomes, etc.)

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
  • Demonstrated knowledge of data management processes and technology
  • Demonstrated ability to understand and apply data flow, data quality, data interchange, data mining, and data representation principles
  • Knowledge of global internal, external and regulatory requirements/expectations (CCS, ICH, GCP, PhRMA, CSUCI etc.)
  • SCDM certification
  • Strong interpersonal and leadership skills
  • Excellent oral and written communication skills
  • Interpersonal/teamwork and communication skills for effective customer consultation
  • Strong business acumen
  • Demonstrated strength in logical thought, problem solving ability and strategic thinking
  • Ability to communicate and influence within Clinical Data Flow and Technology
  • Domestic and International travel may be required
Additional Information
Lilly 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.

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