Clinical Trial Start Up Associate, Romanian

At Lilly, we unite caring with discovery to make life better for people around the world.
We are a global healthcare leader headquartered in Indianapolis, Indiana.
Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
We give our best effort to our work, and we put people first.
We're looking for people who are determined to make life better for people around the world.
Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60nationalities who deliver innovative solutions that add value across a variety of BusinessService functions including Finance, Information Technology, Medical, Clinical Trialsand more.
Eli Lilly Cork offers a premium workspace across our campus in Little Island,complete with flexible hybrid working options, healthcare, pension and life assurancebenefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.
InhousePeople Development services, Educational Assistance, and our 'Live Your BEST Life'
wellbeing initiatives are just some of the holistic benefits that enhance the careerexperience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI).
We cater for alldimensions 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 pillarfor people with disabilities and those that care for them, partners with the Access Lillyinitiative to make our physical and digital environment accessible and inclusive for all.Together they are committed to promoting awareness to create a disability confidentculture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself
The purpose of the
Trial Capabilities Associate
role 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.
The associate is responsible for obtaining clinical trial authorizations and ethical approvals, and activities related to records management and site training.
The associate will ensure inspection readiness through a complete, accurate and readily available Trial Master File.
Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.
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), 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
Qualification Requirements:
Bachelor's degree preferably in a scientific or health related field
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
Effective communication, negotiation, and problem solving skills
Self-management and organizational skills
Native Romanian speaker with fluency in English is essential for this role.
Additional Preferences:
Two years clinical research experience or relevant experience preferred
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 ( ) 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.
Lillydoes 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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