Lilly Consultant-CIPA Clinical Systems in Indianapolis, Indiana
The Clinical Development Organization (CDO), a division of Lilly Research Laboratories, partners with Medical colleagues in Research, Oncology, Biomedicines, and Diabetes to effectively and efficiently design, plan, and execute clinical trials across all phases of research. Uniting experts in clinical development and design, laboratory and data sciences, site engagement, and trial capabilities, the CDO focuses on participants, patients, and investigators to deliver novel designs and innovative research approaches. Our focus on excellence in bringing these capabilities together and providing diverse career opportunities within global clinical development has established Lilly as an industry leader in bringing new medicines to patients.
The Consultant, Clinical Information and Process Automation (CIPA), will serve as the authority for clinical systems supporting clinical development. In this role, you will define and execute implementation plans to deliver on the system strategies, integrations and improvements. The Consultant is responsible for collaborating with business partners to enable development, implementation and support of streamlined, clear and compliant systems to support clinical development. This role will also work closely with external parties including vendors, industry authorities and related organizations to optimize Lilly’s capabilities to support business and customer-focused, efficient clinical development.
Sound interesting to you? Read on to find out the key responsibilities you will have in this role...
Clinical Information Systems Expertise
Understand business strategies, processes and technology as it relates to clinical development
Serve as domain expert to ensure data, process and/or technology interfaces are optimized across other clinical information systems that are integrated with these systems
Support internal audits and external inspections
Define, lead and execute implementation plans to deliver on technology strategies and improvements
Develop critical success factors for pilots/projects and monitor progress to ensure clear criteria exists to enable decision making
Identify, monitor and communicate global customer (internal and external) needs/requirements related to process and/or technology performance and improvements
Lead organizational change, communication planning and training initiatives
Provide guidance and consulting into forecasting expenses
Identify project implementation and system execution risks and raise issues appropriately
Lead progress reporting activities and system metrics to leadership, process owners and end users
Partner with process owners, leadership, Quality and Information Technology to ensure capable, integrated and efficient system usage across the portfolio
Actively participate in shared learning across the team
Work with vendors to improve customer experience and efficiencies
Knowledge and/or experience in organizational change with clinical trial sites, Lilly staff and external parties including vendors, industry experts and related organizations
Knowledge and/or experience in study training/learning management systems and processes
Good interpersonal and leadership skills
Excellent oral and written communication skills
Strong business insight
Demonstrated strength in logical thought, problem solving ability and critical thinking
Ability to communicate and influence across functional boundaries
Ability and experience in positively handling and resolving conflict
Flexibility in approach; able to adjust to unexpected business opportunities while also being a catalyst for change
Knowledge of regulatory and quality requirements governing clinical development
Interest and/or experience in the Shared Investigator Platform (SIP) and study learning management system
Previous Veeva Vault Clinical experience including Study Startup, electronic Trial Master File (eTMF) experience, and/or experience as an owner of TMF records
Interest and/or experience in clinical data management
10% or less travel
Lilly credits its extraordinary employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. Here are a few of the recognitions Lilly has earned for creating an extraordinary work environment:
Business Week magazine 50 Best Places to Launch A Career ™
FORTUNE 50 Best Companies for Minorities ™
Working Mother 100 Best Companies for Working Mothers ™
Science magazine Best Companies for Scientists ™
DiversityInc. Top 50 Companies for Diversity™ (#16 in 2017)
Human Rights Campaign Corporate Equality Index™ – 100% score
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.
Business Integrator-Clinical Systems
Bachelor’s degree in a scientific or health related field
Minimum 3 years’ experience in medical, quality, clinical drug development or clinical information flow
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
Are you seeking a career that makes a difference in the world? Do you have clinical systems expertise? Are you good at interpreting and connecting information from a variety of sources? If so, we have the role for you.
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 global employees 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.
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