Associate / Senior Associate - Trial Capabilities - Spanish Speaking

527 Eli Lilly Cork Limited; Cork; Hybrid; EUR 40,000 - 88,000; Full time

Benefits offered by this job

Subsidised canteen

Onsite gym

Travel subsidies

On-site parking

Pension plan

Healthcare benefits

Education assistance

Wellbeing programs

Job summary

Eli Lilly Cork Limited is seeking a Clinical Research Start-Up specialist to drive site initiation, contract negotiations, and regulatory submissions from Cork. You will coordinate with site teams to ensure timelines and budgets align with corporate priorities, while ensuring regulatory and data privacy requirements are met.

The role emphasizes collaboration, accuracy in documentation, and adherence to compliance standards in a global pharmaceutical environment. Hybrid work options are provided.

Qualifications

• Bachelor’s degree in a scientific or health-related field.
• Two years clinical research experience or relevant experience preferred.
• Understanding of the clinical development paradigm and efficient site initiation.

Responsibilities

• Initiate investigator site activities, including collection and submission of regulatory documents.
• Customize and negotiate 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 contracts and maintain timelines aligned with priorities.
• Populate internal systems and Trial Master Files for future reference.
• Ensure country-specific regulatory and data privacy requirements are incorporated into submission documents.

Skills

Clinical research

Project management

Regulatory compliance

Communication skills

Self-management

Education

Bachelor's degree in science/health

Tools

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.

Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.

Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

Responsibilities

• 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 directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
• 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
• Populate internal systems to ensure accuracy of trial / site performance
• Understand and comply with procurements, legal and financial requirements and procedures
• Populate Trial Master Files and libraries for future reference
• Provide feedback and shared learning for continuous improvement
• Leverage trial prioritization
• Anticipate and monitor dynamically changing priorities

Minimum Qualification Requirements

• Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred
• Understanding of the overall clinical development paradigm and the importance of efficient site initiation
• 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

We encourage employees to discuss the opportunity with their supervisor prior to applying.

Language Capabilities (English and Spanish)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

The anticipated wage for this position is €39,750 - €87,560 Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance).

In addition, Lilly offers a comprehensive benefit program to eligible employees

Benefits

• subsidised canteen
• onsite gym
• travel subsidies
• on-site parking
• Inhouse People Development services
• Educational Assistance
• our ‘Live Your BEST Life’ wellbeing initiatives
• including eligibility to participate in a pension plan
• vacation benefits
• eligibility for healthcare benefits
• flexible benefits (if applicable) life insurance and death benefits
• certain time off and leave of absence benefits
• and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).