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Trial Capabilities Associate

Taipei, Taiwan

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Req ID 55259 Title Trial Capabilities Associate State / Province Taiwan Prov. Country Taiwan Region Asia/Pacific

Company Overview

At Lilly, we are in the early phases of a prolonged period of volume driven growth for the company. We have and will be launching several new molecules in the next couple of years. Our most recent launches position us in some of the most promising classes in biopharma, and we have a world-class go-to-market capability. Lilly is well positioned for the coming years to reach more people who can benefit from our medicines.

At the heart of Lilly's operations are our core values for more than 140 years – Excellence, Integrity and Respect for People. Our values are reflected in business practices that include strong governance principles, the ethical development of medicines, transparency and ethical product promotion. Eli Lilly has received recognition from several distinguished organizations, as example:
  • Catalyst Award, for our innovative Employee Journeys and People Strategy
  • Corporate Knights, Global 100 Most Sustainable Corporations in the World
  • Ethisphere, World's Most Ethical Companies 2019 – 3rd year in a row
  • Forbes, America's Best Employers for Diversity


About Lilly Taiwan
Lilly Taiwan was established more than 50 year ago and we are represented in several major Therapeutic areas like Diabetes, Oncology, Bone Muscle Joint, CNS, Pain and Autoimmune. Lilly Taiwan acts to ensure people are welcomed, valued, respected and heard. You will participate best-in-class launch capabilities with relentless execution and speed, collaborate with diverse people and teams. If you are motivated by helping others to succeed and partnering within a cross-functional team, Join us.

Responsibilities

The purpose of Trial Capabilities Associate is to provide clinical trial capabilities in support of clinical development. The Associate is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out, responsible for obtaining clinical trial authorizations and ethical approvals, execution of the budget and contract, and activities related to clinical finance, records management and site training.
The Associate will also ensure inspection readiness at all times following GCP; any local/regional requirements and Lilly operating procedures and through a complete, accurate and readily available Trial Master File (TMF) as per defined TMF document ownership. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.

As a Trial Capabilities Associate with Lilly, you will need conduct below but not limited to;

  • Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), 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.
  • Communicate with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
  • Communicate with Site Engagement and external party / clinical research organization to enable active collaboration during site activation, maintenance and close-out
  • Manage investigator payments and any other financial transactions related to Trial Capabilities which include, but not limited to, vendor creation and management, PO creation and maintenance, payment activities, country/site budget tracking, and payment-related issue resolution
  • Identify, communicate, and resolve issues
  • Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
  • Leverage previous site / review board engagements to efficiently drive new work
  • Escalate issues to aligned management and quality as appropriate
  • Coordinate the management and delivery of clinical trial material to ensure support of site initiation
  • Coordinate translation process for clinical trial documents and oversight of translation quality
  • Populate internal systems to ensure accuracy of trial / site performance
  • Populate Trial Master Files and libraries for future reference
  • Provide feedback and shared learning for continuous improvement
  • Anticipate and monitor dynamically changing priorities
  • Understand and comply with procurements, legal and financial requirements and procedures
  • Understand, comply, and reinforce local regulations and guidance, Lilly Medical policies and procedures, and good clinical practices (GCP)
55259BR

Basic Qualifications

  • Bachelor’s degree preferably in a scientific or health related field
  • At least one (1) years clinical trial experience or relevant experience preferred

Additional Skills/Preferences

  • Understanding of the overall clinical development paradigm and the importance of efficient site activation
  • 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
  • Language Capabilities – English (read, write, conversation) and local language, as applicable

To submit resume, visit https://www.lilly.com/careers and apply to Req ID 55259.

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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