Clinical Labs/Data Sciences eCOA Associate

Employer
Lilly
Location
Indiana
Salary
Competitive
Posted
April 17 2018
Ref
40368BR
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Pharma
Job Type
Other
Responsibilities
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 with 5 years of experience in clinical operations
  • Or
  • High School Diploma/GED with 10 years of experience in clinical operation
  • 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
  • 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
  • Technical aptitude to use eCOA devices
  • Understanding of clinical data tools and technologies
  • Strong communication skills
  • Strong Project Management skills
  • Strong self-management skills
  • Strong teamwork and interpersonal skills
  • Conceptual understanding of information technology
  • Ability to influence others
  • 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
  • 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

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