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Associate/Snr Associate - Clinical Delivery Capabilities, Cork
Client:
Lilly
Location:
Cork, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
f26f0868079d
Job Views:
63
Posted:
22.01.2025
Expiry Date:
08.03.2025
Job Description:
We’re looking for people who are determined to make life better for people around the world.
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 39,000 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.
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. 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.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself.
Purpose: The purpose of the Clinical Delivery Capabilities Associate/Snr Associate/Manager is to serve as technical and process expert in exploratory and biopharmaceutics clinical development and the management of the portfolio, clinical trials, and business processes. Key areas of support include a) study development and execution activities, b) systems and processes, c) metrics and reporting.
Primary Responsibilities:
1. Establish, maintenance and archival of compound-related files and trial-related files as required per procedures.
2. Given a final protocol, lead the authoring of CT Registry entries at the beginning of a trial.
3. Obtain or prepare relevant documentation necessary for a clinical trial based on GCP or local regulations.
4. Assist in the planning, forecasting, and tracking of trial budgets, POs and invoices.
5. Perform assessments of potential vendors and investigator sites for exploratory and biopharmaceutics clinical development studies.
6. Support efforts in establishing consulting agreements (vendors and investigators).
7. Understand FRAP and consult with teams regarding Financial Responsibility and Authorization Policy compliance.
8. Ensure Legal, Procurement and Financial processes are completed for assigned TPOs.
9. Support study teams with sourcing activities by gaining agreement on sourcing timelines and expectations with the team.
10. Liaising with Procurement to obtain competitive study bids.
11. Preparing Study Work Orders (SWOs) and contracts with Procurement and Legal.
12. Assist study teams with issue escalation and dispute resolution when needed.
13. Participate in ongoing business and quality reviews with TPOs.
14. Work to resolve quality issues arising from internal and external assessments and audits.
15. Work with Global Clinical Budgeting and Contracting to help facilitate the Fair Market Value process.
Minimum Qualification Requirements:
1. Bachelor’s Degree in a scientific or health-related field; or equivalent qualifications/experience.
2. 3 years pharmaceutical industry experience.
Other Information/Additional Preferences:
1. Proficiency with webpage/collaboration site design and stewardship.
2. Strong self-management, analytical and organizational skills.
3. Demonstrated problem-solving abilities.
4. Ability to prioritize and handle a high volume of activities.
5. Proficiency with business software packages.
6. Strong communication (verbal and written) skills and willingness to collaborate globally.
7. Ability to travel (varies dependent on responsibilities – if responsibilities require travel up to 10% expected).
The following may not apply to all individuals, as the job may exist at multiple levels (Associate, Senior Associate and Manager, Senior Manager).
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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