Lead Data Steward-Clinical Data
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
The Clinical Information and Process Automation (CIPA) organization is comprised of centralized and dedicated Process Owners of clinical development processes and System Owners for clinical development systems. We are accountable for the design, sustainability, as well as efficiency and effectiveness of end-to-end global clinical development processes. We are also responsible for the development, implementation, and maintenance of clinical information management and process automation strategies and plans. The processes and systems owned within CIPA are executed by anyone across the company who has a role in the design, planning, execution, and management of clinical trials.
Do you have a passion for continuous improvement? Are you good at identifying opportunities to increase process efficiency and effectiveness? Have you defined and executed implementation plans to deliver a stream-lined process to an organization? If so, we have the role for you.
The Medical Development Unit Information Hub (InfoHub) Program is a joint business and IT initiative with the goal of enabling "on demand access" to information which has been identified as critical in enabling drug development. The InfoHub focuses on establishing a single, digitized source of information which is accessible and usable by downstream development processes and to ensure the quality and timely availability of that information.
In addition, the role provides oversight of information management plans and activities for assigned data domains. The role requires the person to influence broadly across multiple domains, processes, functions, levels and geographies to ensure the accuracy, consistency, and integrity of clinical information that supports global drug development. Other responsibilities of this role include:
- Establish standards and best practices for clinical information management.
- Lead the development of processes and plans for maintaining data quality, including change control processes, and define service-level agreements (as needed) pertaining to availability of the data.
- Provide leadership and oversight to ensure the highest data quality standards, service level agreements are met ensuring the accuracy, integrity, consistency, completeness, and timeliness of the data for assigned domains.
- Ensure processes, data flow, data definitions, and other key information related to the domain are documented and that currency of documentation is maintained.
- Demonstrate detailed understanding of data flow and processes for assigned data domains, including where it is consumed and relationships to other data to assess impact and make decisions regarding requested changes to the data.
- Advise Domain Owner and influence decisions regarding high level best practices and business rules for use of the data.
- Define and actively manage process control metrics for assigned domains; Identify, influence and drive process improvement activities across domains & business areas as needed to maintain appropriate level of control.
- Drive shared learning with team members for other data domains, including those in other functions, to ensure consistency and effective management of cross domain data touch points and relationships.
- Anticipate and resolve key operational or business issues pertaining to data quality.
- Drive organizational and cultural change across drug development organizations related to clinical information quality practices.
- Collaborate with IT to obtain data needed by consumers, including from new data sources.
Business Leadership of InfoHub Projects
- Lead the planning and execution of a group of projects within the InfoHub Program, ensuring appropriate business input and engagement throughout the projects.
- Lead the design/modification of business dataflow and operations.
- Assess and actively manage project risks.
- Identify and promptly address project constraints. Rapidly call out issues for resolution when needed.
- Ensure organizational change management efforts, including communication and training, are in place and effectively executed for assigned projects, and that those efforts align to the overall OCM plans for the InfoHub and other impacted MDU projects and functions.
- Ensure effective integration of business dataflow and operations across projects within InfoHub and with other projects across the MDU.
- Partner with the IT organization, Process & Data Owners, Business SMEs, InfoHub Program Office, and other InfoHub Project Leads to effectively execute program plans.
- Build relationships with and utilize key learning & experience regarding Data Stewardship and clinical information management from areas outside of Medical Research.
- Continually seek and implement means of improving processes to reduce cycle time and decrease work effort resulting in decreased costs and faster access to data.
- Understand the confidential nature of company information and takes necessary steps to ensure its protection along with understanding various aspects of Privacy as it relates to the data
- Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to TPOs or other outside parties Accept obligation to Lilly for compliance to the integrity of the company Complete readings of any policy/procedure updates
- Bachelor's degree
- Work experience in multiple functions of clinical drug development (5 years industry experience)
- Knowledge of and experience with multiple dimensions of clinical research from a process, technology, capability, and organizational perspective
- 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.
- Six Sigma Green Belt or Black Belt experience
- Project Management experience
- Experience leading process change initiatives, particularly those related to technology and data.
- Proven ability to establish and utilized personal and organizational credibility to inspire change
- Strong leadership, interpersonal and communication skills (presentation, verbal and written) and ability to influence, partner and work effectively with others.
- Ability to self-lead with little guidance from others; Strong problem solving skills.
- Flexibility to adjust quickly and effectively to changing business priorities and needs
- 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.