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    Associate / Senior Associate - Clinical Trial Project Management, Exploratory Medicine

    Eli Lily
    3+ years
    Not Disclosed
    Cork
    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 / Senior Associate - Clinical Trial Project Management, Exploratory Medicine
    Location: Cork, Ireland
    Category: Research & Development
    Job Type: Full Time, Regular
    Job Id: R-70529

    Company Overview: At Eli Lilly, we are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees worldwide are dedicated to discovering life-changing medicines, improving disease understanding and management, and contributing to our communities through philanthropy and volunteerism. We pride ourselves on our workforce’s talent, and we strive to provide meaningful career development opportunities. At our Global Business Solutions (GBS) center in Little Island, Cork, we work with a team of over 2000 employees from 38 nationalities, all committed to delivering innovative solutions across a variety of functions, including Clinical Trial Management.

    Position Overview: The Clinical Trial Project Manager (CTPM) Associate will lead cross-functional teams in the development and execution of clinical trials, ensuring high-quality deliverables within scope, budget, and timelines. The position requires strong project management, clinical trial process knowledge, and scientific expertise to drive trial execution and coordinate activities across regions and functions.

    Primary Responsibilities:

    • Project Management & Operational Knowledge:

      • Oversee the development and execution of global clinical trials, including managing scope, timelines, and budgets.
      • Identify and mitigate trial risks using scientific knowledge and regional expertise to ensure the successful delivery of trials.
      • Develop and track global trial enrollment plans, coordinating with regional teams and business partners.
      • Serve as the primary point of contact for all trial communications, collaborating with internal teams and external partners.
      • Proactively address and resolve trial-level issues in a timely and efficient manner.
      • Manage the Trial Master File, ensuring it is current and inspection-ready at all times.

    • Clinical Trial Process Leadership:

      • Lead cross-functional teams throughout study implementation, execution, and closure.
      • Demonstrate deep understanding of clinical trial processes, regulations, and Good Clinical Practice (GCP).
      • Coach and mentor team members and external partners on clinical trial processes and best practices.
      • Monitor and report trial progress, ensuring compliance with global and regional regulatory standards.

    • Scientific Expertise:

      • Utilize scientific knowledge to support clinical trial design, regulatory documentation, and strategic decision-making.
      • Provide technical consultation and draft responses to regulatory agencies and other stakeholders.
      • Contribute to the design and implementation of clinical trial strategies based on scientific, regional, and operational knowledge.

    Minimum Qualifications:

    • Bachelor's or University degree in a scientific or health-related field (advanced degree preferred).
    • A minimum of 3 years of clinical research or relevant experience in a scientific or health-related field.

    Highly Desired Skills:

    • Knowledge of project management methodologies and tools.
    • Proven ability to work with cross-cultural, global teams and Third-Party Organizations (TPOs).
    • Strong leadership, networking, and problem-solving skills.
    • Experience with clinical trial processes, including site-level or affiliate experience.
    • Proficiency with project management tools (e.g., MS Project, MS Excel, MS PowerPoint).
    • Ability to manage complex situations and navigate ambiguity.
    • Excellent communication, self-management, and organizational skills.

    Additional Preferences:

    • Experience in exploratory and biopharmaceutics clinical development.
    • Ability to oversee TPOs and manage trial deliverables.
    • Willingness to travel (up to 10% expected).

    Lilly is an Equal Opportunity Employer: We celebrate diversity and are committed to creating an inclusive environment for all employees. Lilly is dedicated to providing accommodations to individuals with disabilities throughout the application process.

     

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