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 worldwide work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism. We prioritize our work and put people first. We’re looking for dedicated individuals committed to improving lives globally.
Eli Lilly Cork comprises a diverse team of over 2,000 employees from 60 nationalities, delivering innovative solutions across various Business Service functions including Finance, Information Technology, Medical, and Clinical Trials. We offer a premium workspace at Little Island with flexible hybrid options, healthcare, pension, life assurance, subsidized canteen, onsite gym, travel subsidies, and parking. Our holistic benefits also include in-house People Development, Educational Assistance, and wellbeing initiatives like ‘Live Your BEST Life’.
We are committed to diversity, equity, and inclusion (DEI), ensuring representation across ethnicities, nationalities, cultures, generations, sexualities, disabilities, and gender identities through pillars like EnAble, embRACE, LGBTQ+ & Ally, and GIN-Gender Inclusion Network. EnAble, our disability pillar, works with Access Lilly to make our environment accessible and inclusive, fostering a disability-confident culture both locally and beyond.
Join our team — Be Creative, Be an Innovator, and most importantly, Be Yourself!
Purpose:
The Trial Capabilities Senior Manager oversees clinical trial capabilities supporting clinical development. This role ensures investigator sites meet enrollment requirements and support activities during site maintenance and close-out, including regulatory submissions and serving as a point of contact for ERBs and Competent Authorities where applicable. The Senior Manager plans, prioritizes, and implements site initiation activities, collaborating with global and affiliate teams to ensure timely and accurate execution aligned with portfolio needs.
They provide leadership and technical support to Clinical Trial Capabilities Teams, focusing on results and efficiency, and ensure inspection readiness with a complete, accurate Trial Master File.
Primary Responsibilities:
This overview covers current job requirements; these may evolve over time. Consult with your supervisor for specific responsibilities.
Clinical Trial Capabilities Responsibilities:
1. Meet and exceed clinical trial initiation goals for development programs.
2. Ensure site activities comply with regional requirements, data privacy, and Lilly standards.
3. Create and deliver site activation strategies.
4. Manage communications and serve as the primary contact during site initiation, maintenance, and close-out, reporting progress to stakeholders.
5. Prioritize work to meet portfolio needs.
6. Allocate resources flexibly across teams and geographies.
7. Maintain expertise in clinical research and regional regulatory requirements.
8. Develop strategies to enhance customer experience.
9. Ensure inspection readiness with a complete Trial Master File.
Organizational Leadership:
Promote shared learning across the clinical capabilities organization and other functions within CDO and MDU. Build organizational capacity through process, tool, and training improvements, leveraging technology for increased efficiency. Foster a culture of continuous improvement in process, skills, and shared learning.
People Management and Development:
Recruit, develop, and retain a skilled workforce in clinical development. Manage an agile organization responsive to changing portfolios. Cultivate an inclusive, innovative culture that values sound judgment in clinical delivery.
Minimum Qualification Requirements:
* Bachelor’s degree in a scientific or health-related field; five years of clinical research or relevant experience preferred.
* Understanding of clinical development and site initiation importance.
* Previous supervisory experience.
* Strong leadership, influence, and project management skills.
* Experience in compliance-driven environments.
* Ability to understand and adhere to financial and legal guidelines.
* Effective communication, negotiation, and problem-solving skills.
* Organizational and self-management skills.
* Language skills are preferred.
Lilly is committed to accommodating individuals with disabilities. If you require assistance with the application process, please complete the workplace accommodation request form. Lilly upholds equal opportunity employment and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, or other protected statuses.
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