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 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete 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 just some of the holistic benefits that enhance 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 are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
Purpose:
The Trial Capabilities Senior Manager leads the clinical trial capabilities in support of clinical development. The Senior Manager is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out. This includes submission of documents to regulatory authorities and Ethics Review Boards, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), liasing with budget and contract negotiation partner. The senior 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 senior 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 senior manager will ensure inspection readiness at all times 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.
Clinical Trial Capbilities 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 flexilbility 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
Organizational Leadership
Identify and ensure shared learning across the clinical capabilities 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 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
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 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
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.
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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