Join American pharmaceutical leader Eli Lilly and Company, currently hiring Associate / Sr. Associate – Trial Capabilities, Czech/Slovak in Cork, Apply Lilly careers in Cork Cork.
Position : Associate / Sr. Associate – Trial Capabilities, Czech/Slovak
Location : Cork, Ireland
Job id: R-31497
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 35,000 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.Trial Capabilities AssociatePurpose:The Trial Capabilities Associate provides 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, execution of the budget and contract, and activities related to clincial finance, 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. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.Clinical Trial ResponsibilitiesInitiate 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 prioritiesCommunicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-outIdentify, communicate, and resolve issuesEnsure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systemsLeverage previous site / review board engagements to efficiently drive new workPopulate internal systems to ensure accuracy of trial / site performanceUnderstand and comply with procurements, legal and financial requirements and proceduresPopulate Trial Master Files and libraries for future referenceProvide feedback and shared learning for continuous improvementLeverage trial prioritizationAnticipate and monitor dynamically changing prioritiesMinimum Qualification Requirements:Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferredUnderstanding of the overall clinical development paradigm and the importance of efficient site activationApplied knowledge of project management processes and skillsAppreciation of / experience in compliance-driven environmentAbility to learn and comply with financial and legal guidelines and policies (budget and contract)Effective communication, negotiation, and problem solving skillsSelf-management and organizational skillsLanguage CapabilitiesEli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.
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