Sr. Manager - Clinical Trial North America Maintenance Team

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.

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60nationalities who deliver innovative solutions that add value across a variety of BusinessService functions including Finance, Information Technology, Medical, Clinical Trialsand more. Eli Lilly Cork offers a premium workspace across our campus in Little Island,complete with flexible hybrid working options, healthcare, pension and life assurancebenefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. InhousePeople Development services, Educational Assistance, and our ‘Live Your BEST Life’

wellbeing initiatives are just some of the holistic benefits that enhance the careerexperience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for alldimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds,generations, sexuality, visible and invisible disabilities and gender, with four pillars:EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillarfor people with disabilities and those that care for them, partners with the Access Lillyinitiative to make our physical and digital environment accessible and inclusive for all.Together they are committed to promoting awareness to create a disability confidentculture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

About us: This role is located in our Cork GBS office in Little Island.

The Senior Manager Clinical Trial North America Maintenance Team leads the North America Maintenance Team in support of clinical development.This includes leading the countries (US, Puerto Rico, Canada) in the region that support global clinical development. In this role the Senior Manager is accountable for site maintenance/close-out, site contracts amendments, records management, training, and trial metrics across all therapeutic areas. The Senior Manager will serve as the point of contact for Competent Authority (CA)(where applicable), assist in budget and contract negotiation if needed. Additional local responsibilities may be required as needed/appropriate for the local geography, and/or to cover regional differences.

The Senior manager is accountable for the prioritization, planning and implementation of site maintenance activities working closely with the North America Maintenance team, site engagement, global study teams and the design hub ensuring accurate planning, prioritization and timely execution to meet portfolio needs.

The Senior manager provides leadership, direction and technical support to the North America Maintenance Team, focusing on results and driving efficiency to achieve goals and objectives. The Senior manager will ensure inspection readiness at all times by following GCP requirements and through a complete, accurate and readily available Trial Master File .

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.

• Accountable for ensuring site maintenance activities comply with local/regional requirements, data privacy requirements and Lilly quality standards.
• Manage communications/relationships and serve as the point of contact for the trial capabilities deliverable representing progress to business partners internally and externally.
• Support global solutions across geographic regions and in conjunction with other clinical development and MDU functions
• Accountable for prioritisation of work to meet portfolio needs.
• Ensure flexilbility of resources across North America Maintenance Team.
• Provides expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements.
• Develop and manage strategies to improve customer experience.
• Ensure inspection readiness through a complete, accurate and readily available Trial Master File

Organizational Leadership

• Identify and ensure shared learning across the North America Maintenance Team organization and with other functional groups within the CDO and MDU
• Build capabilities in the function through the development and improvement of processes, tools and training and partnering with Clinical Information and Process Automation to leverage technology to increase efficiency of North America Maintenance Team and resources.
• Enable a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning.

People Management and Development

• Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable across the North America Maintenance Team
• Effectively manage an agile organization that continuously meets the needs of a changing portfolio
• Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment based decision making in clinical delivery
• Bachelor’s degree preferably in a scientific or health related field, five years clinical research experience or relevant experience preferred.
• Understanding of the overall clinical development paradigm and the importance of efficient site maintenance
• Previous supervisory experience appreciated
• Strong leadership skills and ability to influence others and lead across the business
• Project management processes and skills
• Appreciation of / experience in compliance-driven environment
• Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
• Effective communication, negotiation, and problem solving skills
• Self-management and organizational skills

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.

Lillydoes 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.

Associate Director - Clinical Central Services and Innovation

Associate / Senior AssociateGlobal Regulatory Affairs-Cork-Regulatory Delivery & Excellence-Global Publisher

Sr. Manager - Clinical Trial North America Maintenance Team

Associate Director - Clinical Central Services and Innovation

Expert Specialist- Trial Capibilities Finance

Trial Capabilities Associate, Contracts and Budgets, Czech Speaking