Global Process and Technology Leader

Employer
Location
Indianapolis
Salary
Competitive
Posted
October 27 2016
Discipline
Life Sciences
Position Type
Full Time
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 Consultant - Process and Technology is responsible for providing technical leadership and process ownership for Data Sciences & Solutions. There are four broad applications/focus areas for this role:
  • Apply broad process/technology knowledge to deliver sustainable strategic capabilities to ensure clinical trial deliverables are consistent and accurate
  • Act as a primary contact within the Clinical Data Flow and Technology organization to ensure organizational structures exist and are equipped to support processes / technologies.
  • Contribute to the development, communication, and adherence to the global data strategy as it relates to process and technology
  • Influence across functions and externally to proactively resolve complex regulatory and business issues related to process and technology
  • Specific domain: This consultant will be accountable to set up a new capability for DSS with regard to data collection using mobile health (mHealth) technologies/devices. The consultant will have broad knowledge of varied aspects of mHealth including but not limited to electronic source (eSource), applicable regulations, overarching data management (DM) processes, DM and IT roles/responsibilities and industry standards for transmission and collection. The consultant will create business processes adhering to security and privacy rules. The new capability will take pilots and proof of concepts to a global scale so operational knowledge and proven operational expertise is key. It will also require vendor management and contracting skills in establishing new mHealth opportunities for DSS
Process/Technology Strategy (35%)
  • Leverage partnerships with external vendors, aligning technical capabilities with internal process and technology business needs
  • Partner and/or strengthen relationships between key providers or customers of clinical data, processes and technologies applicable to focus area to maintain relevancy / currency of business needs.
  • Assess implications of strategic solution options on the clinical portfolio, recommending solutions that deliver increasing quality / efficiency in portfolio delivery
  • Partner with LRL Financial and Procurement to provide a solid financial component to strategic business decisions
  • Drive the creation of project plans that yield tangible strategic deliverables.
  • Support the identification, communication, maturation and adoption of best practices and global standardized business processes, as applicable to focus area.
  • Define, measure and achieve group / organizational proficiency with new tools/technology, processes, and the application of best practices as applicable to focus area.
  • Define and provide guidance related to the transformation of vendor management processes, contracts, etc. resulting from strategy
Implement and Manage Process and Technology Strategy (40%)
  • Drive the design, development and execution of clinical data flow capabilities that increase the quality / efficiency in portfolio delivery
  • Drive the design, development and execution of organizational change to transform / grow organizational competency in support of the clinical data flow to ensure sustainability of solutions over the strategic period
  • Develop track and maintain transformation and support metrics for the strategy
  • Define and provide guidance related to clinical portfolio management
  • Partner with LRL Financial and Procurement to create and manage budgets, work orders, contracts, invoice processing and payments for focus area
  • Provide guidance and consulting into forecasting expenses
Process Improvement (20%)
  • Continually seek and implement means of improving processes to reduce cycle time and decrease work effort to maximize the return of the investment (i.e. technology purchases, vendor agreements, etc) of the assets managed.
  • Represent Data Sciences' processes in cross-functional initiatives
  • Lead shared learning sessions as appropriate across Clinical Data Flow and Technology
  • Identify and leads opportunities 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
Basic Qualifications
  • Bachelor's degree
  • At least 5 years of experience in clinical data management OR 6 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 with additional depth of knowledge in the focus area for the position
  • Demonstrated ability to understand and apply data flow, data quality, data interchange, data mining, and data representation principles
  • Strong knowledge of global internal, external and regulatory requirements/expectations (CCS, ICH, GCP, PhRMA, CSUCI etc.)
  • Ability to influence external strategies of technology vendors, TPOs, CROs and/or standards related organizations
  • Demonstrated ability to communicate and influence within Clinical Data Flow and Technology, across Biometrics and Advanced Analytics, and externally
  • Ability to influence across functions and regions
  • 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
  • Demonstrated ability to communicate and influence within Clinical Data Flow and Technology, across Biometrics and Advanced Analytics, and externally
  • 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.