Associate-Clinical Labs and Data Sciences eCOA Operations

Indianapolis, Indiana
June 27 2019
Life Sciences
Position Type
Full Time
Organization Type
Job Type
The eCOA Operations Associate provides expertise in planning and implementation of electronic modalities in clinical trials within the Clinical Labs and Data Sciences organization (CLDS). The electronic Clinical Outcome Assessment (eCOA) Associate will be responsible for providing guidance concerning technical and process support to the study teams for the following topics: 1) Electronic platform development/execution of instruments intended for data collection (COAs), 2) Copyright, translations, and linguistic validations processes within an eCOA trial, 3) eCOA build processes and project management, 4) Regulatory requirements for eCOA submissions, and 5) Other eCOA related topics. The eCOA Associate 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.

Key Objectives:
  • 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

Company Overview

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.

Basic Qualifications

  • Bachelor's degree
  • Experience with clinical trials

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

Additional Skills/Preferences

  • Demonstrate 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
  • Understanding of clinical data tools and technologies
  • Strong communication skills
  • Strong Project Management skills
  • Strong self-management skills
  • Strong teamwork and interpersonal skills
  • Strong problem solving and communication skills (verbal and written)
  • Conceptual understanding of information technology
  • Strong organizational skills
  • Ability to influence others
  • Detail oriented
  • Ability to handle multiple projects with multiple parties at one time
  • Able to 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

Similar jobs

Similar jobs