Eli Lilly and Company

Associate-CLDS eCOA Operations

Indianapolis, IN, United States
Nov 20, 2018
Required Education
Associate Degree
Position Type
Full time
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.

Do you have a deep expertise in planning and implementation of electronic modalities in clinical trials? Do you seek an opportunity to provide guidance concerning technical and process support to the study teams? If this is an area of interest, we have the role for you.

As an associate in the electronic Clinical Outcome Assessment (eCOA) team, you will develop and execute the electronic platform of instruments intended for data collection. You will work to ensure copyright, translations, and linguistic validations processes are followed within an eCOA trial. You will actively participate in the eCOA build process, project management, and regulatory requirements for eCOA submissions. In this role, you will partner with Data Management personnel, the Site Activation Management Group, the Clinical Trial Project Management (CTPM) organization, Health Outcomes, Medical staff and other functions to assess risks and implement contingencies to meet study milestones. Other responsibilities of this role include:
  • Utilize issue/risk management techniques and strong communication skills to work through vendor, development/implementation and study team issues
  • Lead and influence the study team through an efficient build process
  • Gather and provide feedback to strengthen and enhance processes
  • Recognize big picture, future state connected care, emerging capabilities
  • Utilization of strong understanding of clinical drug development to enhance study team, site and patient experiences with eCOA
  • Contribute to project plan for the eCOA cycle partnering with the copyright /translations and COA vendors as well as study team needs
  • Contribute to vendor oversight process
  • Maintain open lines of communication with management, customers, and vendors to relay critical issues and improve trial level processes related to CLDS deliverables
  • Provide metrics as requested
  • Ensure customers understand CLDS roles and responsibilities
  • Work to improve existing processes and to implement new processes in an efficient manner, including cross-functional process improvement initiatives

Basic Qualifications
  • Bachelor's degree or High School Diploma/GED with 5 years of experience in clinical operations
  • 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 lead the implementation of complex clinical trial development processes and capabilities
  • Demonstrated ability to effectively partner/influence cross functionally to deliver results
  • Demonstrated ability to understand and implement clinical trial processes, including regulatory requirements, risk assessments, mitigation plans, and data quality and integrity
  • Knowledge of clinical data tools and technologies
  • Strong collaboration, communication, and problems solving skills
  • Strong Project Management skills with the ability to organize with detail and handle multiple projects with multiple parties at one time
  • Strong self-management skills
  • Conceptual understanding of information technology
  • Ability to influence others and drive teams towards timelines and negotiate timeline needs between vendors and teams
  • Technical aptitude to use eCOA devices
  • Thrives in a fast pace, constantly changing environment

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.