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Clinical Trial Start Up Manager

Cork, Ireland

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Req ID R-828 Title Clinical Trial Start Up Manager City Cork State / Province Cork Country 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 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. We’re looking for people who are determined to make life better for people around the world.

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 800 of whom are based at our Global Business Solutions centre in Little Island, Cork.  There we boast vibrant workforce made up of over 44 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, Procurement, Trail Capabilities, Global Scientific Communications and more to come on stream across 2020.

This, along with the 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 extends our overall capacity to in excess of 1000 employees where Lilly will continue to offer a premium workspace across both buildings, complete with healthcare, pension and life assurance benefits, subsidised canteen, wellbeing facilities, barista, gym, 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.

Job description

The Clinical Trial Start Up Manager leads and manages the daily operation of the clinical trial capabilities team in support of clinical development.  The Manager is accountable for ensuring accurate planning, prioritization across teams and timely execution working closely with site engagement at the affiliates and across the trial capabilities teams. The scope of the work includes activities related to investigator sites readiness; maintenance and close out ensuring country specific requirements are met.  The manager is responsible for ensuring inspection readiness through a complete, accurate and readily available Trial Master File.

The manager provides leadership, direction and technical support to the Clinical Trial Start Up Assistants focusing on results and driving efficiency to achieve goals and objectives.

Responsibilities

  • Accountable for meeting and exceeding goals for clinical trial operations for development programs.
  • Accountable for ensuring site initiation and 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 team deliverables during site initiation, maintenance, and close out representing progress to business partners.
  • Accountable for daily prioritisation of work to meet business needs
  • Provides expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements.
  • Develop and streamline processes ensuring efficiency and improved productivity as well as meeting customer requirements
  • Ensure inspection readiness through a complete, accurate and readily available Trial Master File

Organizational Leadership

  • Identify and ensure shared learning across the clinical capabilities organization and with other functional groups within the CDO
  • Build capabilities in the function through the development and improvement of processes, tools and training.
  • 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

Qualification Requirements:

  • Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred
  • Understanding of the overall clinical development paradigm and the importance of efficient site initiation
  • Previous supervisory experience
  • 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
  • Language capabilities preferred

Additional Skills/Preferences

The GBS focuses on the following foundational pillars across the full organisation to ensure a solid and consistent approach to running our business

Compliance

  • Demonstrate a strong compliance oriented mindset & help to build a strong compliance culture
  • Familiarize with & influence all applicable process documentation & training materials to ensure you operate in a fully compliant manner

People

  • Actively participate in the GBS senior management team to make the GBS a great place to work for all employees and influence the strategic direction of the center
  • Engage interpersonal, communication & relationship building skills to interact with all levels of an organization

Customer

  • Demonstrate excellence in all interactions with our GBS internal customers & business partners
  • Focus on measuring & improving our internal customer’s experience with the GBS


Continuous Improvement

  • Lead a culture of continuous improvement within the CDO organization and the broader GBS
  • Influence the Global process owners to champion continued process improvement

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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-828.

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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