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Lilly Senior Manager - Clinical Trial North America Maintenance in Cork, Ireland

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 35,000 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 people around the world.

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

At Lilly, we make a difference for people the world over by discovering, developing and delivering medicines that help people live longer, healthier and more active lives. Central to all that we do are our talented and motivated professionals. There we boast a vibrant workforce made up of over 35 nationalities, speaking over 27 languages.

Established in 2010 to gain efficiencies in Finance GBS Cork quickly excelled in its financial mandate, allowing the Cork leadership to ask, how can we apply these processes to other areas of the business? And so the GBS we have today was born, still leading in finance, but also evolving and expanding into diverse Business Service functions.

This, along with the current physical expansion of the Little Island campus, means there has never been a more exciting time to be part of the GBS story! The new Island Hall facility will extend our overall capacity where Lilly will continue to offer a premium workspace across both buildings.

Our benefits package includes healthcare, pension and life assurance benefits, subsidised canteen, wellbeing facilities, Educational Assistance, travel subsidies, car-pooling incentives, bike to work scheme, on-site parking and much more..

Above all, it’s about being part of an open, welcoming and inclusive culture, one that is further enhanced by the dedication of our committees - Culture Club, Diversity & Inclusion, Sports & Social, Corporate Social Responsibility, Health Safety & Environment and Food

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.

North America Maintenance Responsibilities

  • 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

Minimum Qualification Requirements:

  • 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

Eli 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 ( ) 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.