Associate / Senior Associate - Trial Capabilities Associate

2+ years

Not Disclosed

Cork

10 Jan. 31, 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 - Trial Capabilities Associate
Location: Cork, Cork, Ireland
Category: Research & Development
Job Type: Full-Time, Regular
Job Id: R-78203

Company Overview

At Eli Lilly, we are a global healthcare leader committed to making life better for people around the world. Our employees are united by our mission to discover, develop, and deliver life-changing medicines that help people live longer, healthier lives. At our Cork campus, we have a diverse and talented team of over 2,000 employees from more than 60 nationalities, contributing to a wide range of business service functions, including finance, IT, medical, and clinical trials.

Eli Lilly Cork offers a collaborative and flexible working environment with hybrid options, a comprehensive benefits package, and initiatives that focus on employee well-being, including fitness programs, educational assistance, and a variety of diversity and inclusion initiatives.

Position Overview

The Trial Capabilities Associate is a key role within the clinical development team, responsible for supporting clinical trials by ensuring that investigator sites meet the requirements for study participant enrollment. This includes activities related to clinical trial authorizations, ethical approvals, site training, and ongoing maintenance of trial records. The associate ensures that all documentation is inspection-ready and compliant with regulatory requirements.

Key Responsibilities

Clinical Trial Support

Initiate investigator site activities, including collection and submission of regulatory documents.
Customize and negotiate informed consent documents with site personnel.
Serve as the primary point of contact for site’s Ethical Review Boards (ERB) and Competent Authorities (CA), as applicable.
Negotiate budgets with site personnel and internal teams, ensuring alignment with project timelines.
Track and ensure that sites comply with required training and drive timely project milestones.
Communicate and collaborate with sites during study start-up, maintenance, and close-out phases.
Identify, resolve, and escalate issues that may impact timelines or quality.

Documentation & Compliance

Ensure that country-specific regulatory and data privacy requirements are incorporated into all relevant documents and submissions.
Maintain an accurate Trial Master File (TMF) and populate internal systems with trial/site performance data.
Manage records in accordance with applicable legal, procurement, and financial requirements.

Process Improvement & Team Collaboration

Provide feedback to the team to continuously improve processes.
Share best practices and learnings from past site engagements to facilitate smooth project execution.
Monitor and adjust to dynamically changing priorities to support the success of clinical trials.

Qualifications

Required

Bachelor’s degree in a scientific or health-related field.
Strong understanding of clinical development processes, especially site activation and trial management.
Applied knowledge of project management processes and skills.
Excellent communication, negotiation, and problem-solving skills.
Fluency in English and Portuguese (essential).
Self-management and organizational skills to handle multiple priorities efficiently.

Preferred

Two years of clinical research experience or relevant experience in the pharmaceutical industry is preferred.

Additional Information

Eli Lilly is committed to fostering an inclusive work environment and actively encourages individuals with disabilities to engage in the workforce. If you require accommodations during the application process, please complete the accommodation request form available on our careers page.

Eli Lilly is an EEO/Affirmative Action Employer and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

Benefits

Comprehensive benefits package, including healthcare, pension, and life assurance.
Hybrid working options, flexible work-life balance, wellness initiatives, and employee development programs.

#WeAreLilly

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Associate / Senior Associate - Trial Capabilities Associate

Job Description

Company Overview

Position Overview

Key Responsibilities

Qualifications

Additional Information

Benefits

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