Clinical Delivery Capabilities, Contracts and Budgets Associate/Manager

at  Lilly

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.
At Eli Lilly Cork, 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 41,000 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 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.
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised 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.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
Purpose: The purpose of the Clinical Delivery Capabilities Contracts and Budgets Associate/Manager/Snr 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) Study Related Contracting and Budgeting, c) metrics and reporting. In addition to knowledge of ICH and quality guidelines needed for successful delivery of the portfolio and clinical trials, the CDC possesses the business acumen, process knowledge, and influence required to substantively participate in process and quality improvement efforts as well as roll out necessary training for the department. The CDC Associate/Manager 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.
• 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

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 templates
• Support 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.
• Identify, evaluate, and interrelate data using means to advise business processes and enable organization decisions, investigate issues, and identify trends and improvement areas.
• 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 databases
• Work to assess vendor performance, share TPO performance metrics with Lilly management.
• Manage and maintain Org Charts and Job Descriptions for EMP

MINIMUM QUALIFICATION REQUIREMENTS:

• Bachelor’s Degree in a scientific or health-related field; or equivalent qualifications/experience (3 years pharmaceutical industry experience).
• Experience with contract management with vendors and/or clinical sites.
• 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

Please refer the Job description for details