Associate/Snr Associate - Clinical Delivery Capabilities
Eli Lilly
- Cork
- Permanent
- Full-time
Activate Sites and Maintain Active Sites (e.g. New Trial Statements for insurance certificates, copyright permissions and document translations, Clinical Trial Applications)Assist in the planning, forecasting, and tracking of trial budgets, POs and invoices.Perform assessments of potential vendors and investigator sites for exploratory and biopharmaceutics clinical development studies.Support efforts in establishing consulting agreements (vendors and investigators).Understand FRAP and consult with teams regarding Financial Responsibility and Authorization Policy compliance.Ensure Legal, Procurement and Financial processes are completed for assigned TPOs.Support study teams with sourcing activities by:Gaining agreement on sourcing timelines and expectations with the team.Liaising with Procurement to obtain competitive study bids.Preparing Study Work Orders (SWOs) and contracts with Procurement and Legal.Assists study teams with issue escalation and dispute resolution when needed.Serving as main business contact to assigned TPOs.Participate in ongoing business and quality reviews with TPOs.Work to resolve quality issues arising from internal and external assessments and audits.Work with Global Clinical Budgeting and Contracting to help facilitate the Fair Market Value process.Systems and Processes Support:Create and maintain collaboration sites at process, compound or trial levels for the organization.Proactively establish and ensure accuracy and completeness of information in Clinical Trial Management systems and other critical business systems, producing reports as needed.Coordination and process ownership (e.g. SPR, Study Sourcing Mtg, etc.).Collaborate in the development and maintenance of business processes for assigned TPOs (e.g. operations guides).Represents Clinical Delivery Capabilities group in the assessment and contracting of potential vendors as appropriate.Coordinate and conduct clinical operations, quality and privacy assessments/qualification of vendors and Investigator sites (networking with appropriate technical experts as necessary). Includes Anti-corruption due diligence.Maintain up-to-date inventory of approved and potential external vendors and INV sites.Help maintain study archetype templatesSupport record retention activities for the organization.Provide support for Training curricula assignment and system updates.Provide support in the Protect Lilly / Privacy / GDPR (EU) / other compliance initiatives.Metrics, Reporting and Systems Maintenance:Create and run reports for metrics as well as proactively address gaps in required fields.Support reviews of GCP issues and compliance reporting.Generate organizational metrics/measures, milestone reports, capacity reports, and other reports as needed (e.g. bottleneck reports)Support capacity planning and accurate reporting of project time through coordination of PRISM entries.Support use of systems and databasesWork to assess vendor performance, share TPO performance metrics with Lilly management.Manage and maintain Org Charts and Job Descriptions for EMPMinimum Qualification Requirements:Bachelor’s Degree in a scientific or health-related field; or equivalent qualifications/experience3 years pharmaceutical industry experience.Other Information/Additional Preferences:Proficiency with webpage/collaboration site design and stewardshipStrong self-management, analytical and organizational skills.Demonstrated problem-solving abilities.Ability to prioritize and handle a high volume of activities.Proficiency with business software packagesStrong communication (verbal and written) skills and willingness to collaborate globally.Ability to travel (varies dependent on responsibilities – if responsibilities require travel up to 10% expectedThe following may not apply to all individuals, as the job may exist at multiple levels (Associate, Senior Associate and Manager, Senior ManagerKnowledge and understanding of:Technical details of clinical study protocols, especially as regards subject inclusion/exclusion criteria, schedules of events and procedures.Experience in clinical development, familiarity with medical terminology, and good clinical practice requirements.Exploratory and biopharmaceutics clinical development study processes, clinical site operationsEli 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.#WeAreLilly