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Trial Capabilities Associate/Senior Associate/Manager- Project Management

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Lilly

1mo ago

  • Job
    Full-time
    Junior Level
  • Research & Development
    Healthcare
  • Cork

AI generated summary

  • You need a relevant degree, 2 years of clinical research experience, project management skills, compliance knowledge, strong communication, and an understanding of clinical development and regulations.
  • You will guide study teams on documentation, track deliverables, communicate timelines, address delivery issues, manage process improvements, and ensure compliance for trial packages.

Requirements

  • Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred
  • Applied knowledge of project management processes and skills
  • Appreciation of / experience in compliance-driven environment
  • Effective communication, negotiation, and problem-solving skills
  • Self-management and organizational skills
  • Excellent communication (written and verbal) skills
  • Strong knowledge of data privacy regulations, intellectual property, and clinical trial regulations
  • Ability to make business-driven decisions
  • Understanding of the overall clinical development paradigm and the importance of efficient site activation

Responsibilities

  • Responsible for providing guidance to the study team regarding Lilly required and regulatory required documentation, processes, and other aspects of the complete trial package
  • Partner with Design Hub, Clinical Development, CMC, Trial capabilities in all regions, and associated Third Party Organizations (TPOs) to ensure document requirements for each trial are defined, documented, and delivered within agreed upon timelines to allow on-time delivery of the complete trial package
  • Create, update, and track document requirements and delivery in the regulatory document tracker at the trial level
  • Communicate timelines with appropriate study team members and implement risk mitigation and contingency plan strategies on behalf of the study teams to ensure on-time document delivery
  • Drive timelines-based study priority ensuring accelerated novel approaches are adopted for Game Changers and Potential Game Changers
  • Escalate document delivery issues, as appropriate
  • Responsible for initiating the insurance certificate process for all countries participating in the trial where applicable
  • Responsible for ensuring all documents required from the global study team for initial country submissions are provided to the affiliates and TPO partners
  • Responsible for the development and utilization of appropriate document delivery planning and tracking tool(s), serving as the owner of communication across the study team, affiliates and TPOs utilizing critical thinking and problem-solving skills to hold business partners accountable for delivery
  • Populate internal systems to ensure accuracy of trial / site performance
  • Understand, comply with, and promote complete trial package process improvements and technology systems as well as identify suggested process improvements
  • Provide feedback and shared learning for continuous improvement
  • Anticipate and monitor dynamically changing priorities

FAQs

What is the purpose of the Trial Capabilities Associate position?

The Trial Capabilities Associate is accountable for ensuring the Complete Trial Package (CTP) required for Regulatory and Ethics committee submission includes all necessary regulatory documents for initial Clinical Trial applications and any subsequent submissions for all participating countries globally.

What are the main responsibilities of the role?

Key responsibilities include providing guidance on required documentation, partnering with various teams to ensure timely delivery of documents, creating and tracking document requirements, communicating timelines, driving study priorities, and ensuring compliance with trial package processes.

What qualifications are required for this position?

A Bachelor’s degree in a scientific or health-related field is preferred, along with two years of clinical research experience or relevant experience, knowledge of project management processes, effective communication skills, and strong organizational skills.

Are there additional preferences for candidates?

Yes, additional preferences include excellent communication skills, strong knowledge of data privacy regulations and clinical trial regulations, and the ability to make business-driven decisions.

What is the work environment like at Eli Lilly Cork?

Eli Lilly Cork offers a premium workspace with flexible hybrid working options, a range of benefits including healthcare and wellness initiatives, and a commitment to diversity, equity, and inclusion.

How does Lilly support employees with disabilities?

Lilly is dedicated to ensuring equal opportunities for individuals with disabilities and offers accommodations during the application process.

What therapeutic areas does this position support?

The role supports trials being initiated in Phase I-IV across all therapeutic areas.

Which teams will the Trial Capabilities Associate work with?

The associate will collaborate with the Design Hub, Clinical Development, CMC, Trial capabilities in all regions, and associated Third Party Organizations (TPOs).

What is the importance of the role in relation to clinical trials?

The role is crucial for ensuring the prompt and accurate submission of regulatory documents, which is vital for the successful initiation and conduct of clinical trials.

What does the company value most in its employees?

Lilly values determination to improve lives, creativity, innovation, collaboration, and the authentic expression of oneself.

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Lilly

We're a medicine company turning science into healing to make life better for people around the world.

Manufacturing & Electronics
Industry
10,001+
Employees
1876
Founded Year

Mission & Purpose

Eli Lilly and Company is a global pharmaceutical firm dedicated to discovering, developing, and delivering innovative medicines that improve patient outcomes worldwide. Their ultimate mission is to make life better for people around the globe through high-quality healthcare solutions. The purpose of the company is to create medicines that help people live longer, healthier, and more active lives, while maintaining a commitment to ethical standards, scientific excellence, and integrity in all their operations.

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