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Associate/Sr. Associate - Clinical Trial Foundations (Ctf) Clinical Systems Management

1-3 years
Not Disclosed
10 Jan. 30, 2025
Job Description
Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate/Sr. Associate - Clinical Trial Foundations (CTF) Clinical Systems Management
Location: Cork, Cork, Ireland
Category: Research & Development
Job Type: Full Time, Regular
Job ID: R-76226

About Eli Lilly:

At Eli 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, with employees working to discover life-changing medicines, improve disease understanding and management, and give back to communities through philanthropy and volunteerism. We put people first and are looking for individuals dedicated to improving the lives of patients globally.

At Eli Lilly Cork, we foster a creative and inclusive work environment where innovation thrives. We have a diverse team of over 2,000 employees representing 60 nationalities. Our employees benefit from a variety of holistic benefits, including healthcare, pension plans, life assurance, wellness programs, and more.

Role Overview:

The Clinical Systems Management role, part of the Clinical Trial Foundations (CTF) within Clinical Design, Delivery & Analytics (CDDA), focuses on managing the systems used for clinical trials. Based at our Global Business Solutions (GBS) center in Cork, this role involves daily functional interactions with the wider team in the US. You will support operational, compliance, and quality aspects of CDDA business systems, ensuring they are optimized to speed the delivery of medicines globally.

You will work closely with various internal teams, such as CDDA, Tech@Lilly, and other R&D units, to support business processes and system lifecycle management. This includes understanding data flows, requirements gathering, system compliance, and providing ongoing support for system releases and user training.

Key Responsibilities:

  • System Management: Develop and maintain in-depth knowledge of systems used across CDDA for clinical trials.
  • Technical Support: Provide technical expertise in managing CDDA business systems, coordinating deployment, support, maintenance, and updates.
  • System Releases & Patches: Assist with the installation of new releases, patches, and updates by providing technical support and business process development.
  • Issue Resolution: Troubleshoot system issues quickly, applying root cause analysis as needed to ensure continued access.
  • System Risk Management: Identify and raise concerns regarding system risks and issues, proactively managing any challenges that arise.
  • User Support: Provide support to system users, addressing queries and incidents in line with Service Level Agreements (SLAs).
  • Training & Documentation: Develop and maintain training materials, FAQs, and job aids to ensure users are well-supported. Conduct user training as necessary.
  • Audit Support: Assist with internal audits and external inspections related to system use.
  • Metrics & Reporting: Maintain and develop system performance metrics to track progress and identify areas for improvement.

Minimum Qualifications:

  • Education: Bachelor’s degree in Computer Science, IT, or a related field (or equivalent work experience).
  • Experience: Applied experience in clinical drug development, medical systems, or clinical information flow is preferred.
  • Skills:
    • Excellent written and verbal communication skills; ability to communicate effectively with team members and leadership.
    • Strong problem-solving abilities; able to diagnose root causes and implement corrective actions.
    • Strong organizational skills with the ability to prioritize and manage workload effectively.
    • Ability to adapt to frequent changes and shifting priorities.

Additional Information:

  • Location: Cork, Ireland – with flexible hybrid working options available.
  • Work Environment: Diverse team with a focus on inclusivity and employee well-being.
  • Benefits: Comprehensive benefits package including healthcare, pension, wellness initiatives, and more.

Equal Opportunity Employer:

Lilly is committed to promoting diversity, equity, and inclusion (DEI). We are dedicated to making our physical and digital environment accessible for all, supporting employees of all backgrounds, identities, and abilities.