Trial Capabilities Manager

Overview
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 work to discover and bring life-changing medicines to those who need them, improve understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
We put people first and seek individuals 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 60 nationalities who deliver innovative solutions across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Eli Lilly Cork offers a premium workspace on our campus in Little Island, 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 part of 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, embRACE, LGBTQ+ & Ally 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 promote awareness to create a disability confident culture at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself
Job description
The Trial Capabilities – Manager Operations 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 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 Capabilities assistants focusing on results and driving efficiency to achieve goals and objectives.
Key Objectives / Deliverables
Clinical Trial Capabilities Responsibilities
Accountable for meeting and exceeding goals for clinical trial budgets and contracts operations for development programs.
Accountable for ensuring compliance 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 budgets and contracts 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 from legal/health science/finance/engineering field), six years clinical research experience or relevant experience essential
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
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
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 at 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.
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.
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