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Senior Manager Trial Capabilities

Cork, Munster

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Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help with individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process for positions at Lilly please email Lilly Recruiting Compliance for further assistance. Please note, this email address is intended for use only to request an accommodation as a part of the application process. Any other correspondence will not receive a response.

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Req ID 53742 Title Senior Manager Trial Capabilities City Cork State / Province Cork Country Ireland Region Europe; Middle East; Africa

Company Overview

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, circa 500 of whom are based at our Global Business Solutions centre in Little Island, Cork. There we boast vibrant workforce made up of over 35 nationalities, speaking over 27 languages.

Established in 2010 to gain efficiencies in areas such as General Accounting, Purchase to Pay and Order to Cash, the 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 including Customer Meeting Services, Global HR Data Management, Medical Information and more to come on stream across 2018 and 2019.

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! Mirroring the existing Island House building, the new Island Hall facility will extend our overall capacity where Lilly will continue to offer a premium workspace across both buildings, complete with healthcare, pension and life assurance benefits, subsidised canteen, wellbeing facilities, travel subsidies, car-pooling incentives, bike to work scheme, on-site parking and much more.

At the GBS, it’s not just about what we do today, but how we can continuously improve and innovate for present and future operations. We view the development of our highly skilled workforce in much the same way and want to grow your role into an empowering and fulfilling career here at Lilly. Therefore, with the sole purpose of employee progression, weekly Manager 1:1s, a dedicated Learning & Development service and Educational Assistance schemes all await you.

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.

“We see Cork as an integral part of our productivity agenda. If you are excited by new opportunity and new scope, you are working at the right place.” – Dave Ricks, CEO Lilly

The Clinical Trial Capabilities Team will be based at Lilly’s newly expanded office facility in Little Island and will focused on clinical research and, in particular, clinical study start-up activities across the EU and other regions, e.g. Middle East, Africa and Russia. The Clinical Trial Capabilities Centre will allow us to provide an unparalleled clinical trial experience for investigators and patients and ultimately achieve Lilly’s goal of speeding innovation and bringing our medicines to patients who need them

Responsibilities

The Trial Capabilities Manager leads the clinical trial capabilities in support of clinical development. The Manager is accountable to ensure the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities during site maintenance and closeout. This includes submission of documents to regulatory authorities and Ethics Review Boards (ERB), serve as the point of contact for a site’s ERB and Competent Authority (CA) (where applicable), assist in budget and contract negotiation. The manager is accountable for the prioritisation, planning and implementation of site initiation activities working closely with the site engagement at the affiliates, global study teams and the design hub ensuring accurate planning, prioritisation and timely execution to meet portfolio needs.

The manager provides leadership, direction and technical support to the Clinical Trial Capabilities Teams focusing on results and driving efficiency to achieve goals and objectives. The manager will ensure inspection readiness at all times through a complete, accurate and readily available Trial Master File.

Key Objectives / Deliverables:
  1. Clinical Trial Capabilities Responsibilities
    • Accountable for meeting and exceeding goals for clinical trial initiation for development programs.
    • Accountable for ensuring site initiation and maintenance activities comply with local/regional requirements, data privacy requirements and Lilly quality standards.
    • Drive and ensure Site Activation strategies are created and delivered.
    • Manage communications/relationships and serve as the point of contact for the trial capabilities deliverable during site initiation, maintenance, and close out representing progress to business partners.
    • Accountable for prioritisation of work to meet portfolio needs.
    • Ensure flexibility of resources across trial capabilities teams and geographies.
    • 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


  1. Organizational Leadership
    • Identify and ensure shared learning across the clinical capabilities organization and with other functional groups within the CDDA 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 clinical trial capabilities 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 in clinical development
    • 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

53742BR

Basic Qualifications

  • Bachelor’s degree preferably in a scientific or health related field, five years clinical research experience or relevant experience preferred
  • Minimum 2-3 years managing teams
  • Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in clinical development
  • Effectively manage an agile organization that continuously meets the needs of a changing portfolio
  • Understanding of the overall clinical development paradigm and the importance of efficient site initiation
  • 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

Additional Skills/Preferences

2-3 years people management is essential for this position.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID 53742.

Lilly is an EEO/Affirmative Action Employer and 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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