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 patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Lilly offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidized canteen, onsite gym, travel subsidies and on-site parking. In-house 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.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! Purpose:
The purpose of the Clinical Delivery Trial Associate role is to serve as technical and process expert in exploratory and biopharmaceutics clinical development and the support of the portfolio, clinical trials, and business processes. Key areas of support include: a) study development and execution systems and processes, b) study related contracting and budgeting and c) metrics and reporting. In addition to knowledge of ICH and quality guidelines needed for successful delivery of the portfolio and clinical trials, the CBO Associate possesses the business acumen, process knowledge, and influence required to substantively participate in process and quality improvement efforts. The Associate will seek knowledge from internal and external sources and use this information to shape continuous improvement opportunities.
Primary Responsibilities: This job description is intended to provide a general overview of the various job requirements. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with supervision regarding actual job responsibilities and any related duties that may be required for the position.
Study Development and Execution Support: Establish, maintenance and archival of compound-related files and trial-related files as required per procedures.
Create and maintain clinical plan and compound information in IMPACT.
Given a final protocol, lead the authoring of CT Registry entries at beginning of a trial.
Obtain or prepare relevant documentation necessary for a clinical trial based on GCP or Local regulations for Site Activation, Maintenance and Close-out (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.
Support efforts in establishing consulting agreements (vendors and investigators).
Understand FRAP and consult with teams regarding FRAP 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.
Participate in ongoing business and quality reviews with TPOs.
Work to resolve quality issues arising from internal and external assessments and audits.
Work with corporate contracts group to help facilitate the FMV 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 Veeva Vault Clinical, IMPACT, Planisware and other critical business systems, producing reports as needed.
Collaborate in the development and maintenance of business processes.
Represent the Clinical Business Operations in the assessment and contracting of potential vendors as appropriate.
Includes Anti-corruption due diligence.
Help maintain study archetype templates.
Support knowledge management and archival activities for the organization.
Provide support for tools to support portfolio delivery.
Provide support for Training curricula assignment and system updates.
Provide leadership in the Protect Lilly / Privacy / GDPR (EU) / other compliance initiatives.
Metrics, Reporting and Systems Maintenance: Identify, evaluate, and interrelate data using means to advise business processes and enable organization decisions, investigate issues, and identify trends and improvement areas.
Create and run system 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, staff capacity reports, and other reports as needed (e.g. bottleneck reports).
Support capacity planning and accurate reporting of project time through coordination of CATS entries.
Support use of systems and databases (for example: Trackwise deviation or change mgmt systems).
Work to assess vendor performance, share TPO performance metrics with Lilly management.
Manage and maintain Org Charts and Job Descriptions.
Basic Requirements: Bachelor's Degree in a scientific or health-related field; or equivalent qualifications/experience (3 years pharmaceutical industry experience).
Strong self-management, analytical and organizational skills.
Demonstrated problem-solving abilities.
Ability to prioritize and handle a high volume of activities.
Proficiency with business software packages.
Strong communication (verbal and written) skills and willingness to collaborate globally.
Ability to travel (varies dependent on responsibilities – if responsibilities require travel up to 10% expected).
Additional Skills/Preferences: The following may not apply to all individuals, as the job may exist at multiple levels (Associate, Senior Associate and Associate Consultant):
Knowledge and understanding of:
Technical details of clinical study protocols, especially as regards subject inclusion/exclusion criteria, schedules of events and procedures.
Experience with contract management with vendors and/or clinical sites.
Proficiency with webpage/collaboration site design and stewardship.
Operational data analysis in excel and various reporting systems.
Experience in clinical development, familiarity with medical terminology, and good clinical practice requirements.
Exploratory and biopharmaceutics clinical development study processes, clinical site operations.
Experience with Veeva Clinical, Office 365, data visualization software (e.g. Tableau Vault, PowerBI).
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.
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