Associate / Senior Associate - Trial Capabilities - Spanish Speaking

Eli Lilly Eli Lilly · Pharma · Cork, Ireland

Associate/Senior Associate role focused on clinical trial site initiation and management, requiring regulatory document submission, budget negotiation, contract management, and ensuring site compliance. The role involves communication with sites, regulatory authorities, and internal teams, with a strong emphasis on compliance with regulatory, data privacy, financial, and legal requirements. Fluency in both English and Spanish is required.

What you'd actually do

  1. Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents,
  2. Serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable)
  3. Communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities
  4. Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out. Identify, communicate, and resolve issues.
  5. Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems

Skills

Required

  • Bachelor’s degree preferably in a scientific or health related field
  • two years clinical research experience or relevant experience
  • Understanding of the overall clinical development paradigm and the importance of efficient site initiation
  • Applied knowledge of project management processes and skills
  • Appreciation of / experience in compliance-driven environment
  • Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
  • Effective communication, negotiation, and problem solving skills
  • Self-management and organizational skills
  • English and Spanish Language Capabilities

What the JD emphasized

  • Spanish Speaking
  • compliance-driven environment
  • financial and legal guidelines
  • regulatory documents
  • negotiation