Clinical Trial Operations Manager

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.

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60nationalities who deliver innovative solutions that add value across a variety of business 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. In-house People Development services, Educational Assistance, and our 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.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself

The Clinical Central Services and Innovation organization orchestrates solutions that enhance clinical research awareness and accessibility while increasing diversity, reducing burden and speeding trial execution. This group partners across functions within Clinical Design, Delivery and Analytics (CDDA) and Product Research and Development (PRD) to influence trial design and operationalize innovation solutions to support the execution of clinical trials globally for all business units across all phases of development.

To help solve unmet needs in healthcare across diverse populations, Lilly is expanding its use of Decentralized Clinical Trials (DCT), a model that utilizes technology and processes to create options for a more patient-centric experience when participating in clinical trials, beyond an exclusive physical presence at research sites. Telemedicine and Virtual Orchestration (TeVO) leverages technology to enable flexibility and convenience for patients, investigators, and research staff. The role of TeVO Associate within the Clinical Central Services and Innovation Team will facilitate the delivery and implementation of the TeVO strategy within Lilly's clinical research portfolio.

Primary Responsibilities:

• Drive implementation of telemedicine and virtual trial orchestration processes from trial startup to close out within clinical programs to increase accessibility of clinical trial participants globally.
• Collaborate with cross functional teams to understand clinical program timelines, objectives, and requirements to develop, align and execute implementation strategies to meet/exceed goals.
• Develop operational plans to document roles, responsibilities, and expectations across Lilly and the selected vendor(s).
• Oversee and manage vendor performance on a trial.
• Manage and resolve issues in a timely manner. Monitor and track trends to influence and drive solutions and/or process improvements.
• Manage implementation deliverables and ensure ongoing communication with cross functional business partners.
• Track and collate data related to the delivery and implementation of the telemedicine strategy including elements related to budgets, vendor management and/or technology platforms to support reporting and metrics.
• Continuously maintain a state of inspection readiness. Participate and perform duties required for internal and external inspections as well as supporting institutions/investigators and alternative site locations in inspection readiness initiatives.

Contribute to an inclusive and innovative culture:

• Partner and/or strengthen relationships across business partners and vendors to identify and communicate best practices and share learnings.
• Collaborate with study teams, research personnel and vendors to enhance the experience of our study participants and enable optimized strategy delivery.
• Develop and evolve knowledge of the clinical development landscape to support the overarching strategy.

Support continuous improvement

• Continually seek and drive process improvement or process automation opportunities to reduce cycle time and decrease work effort.
• Embrace and support quality improvement initiatives.
• Support the development of training materials, job aides and resources for areas of focus.

Minimum Qualification Requirements

• Degree in Computer Science, Engineering, Information Systems, or related field.
• 3 years prior experiences in one of the following: data analytics and experience with API integration and automation. Solid understanding of cloud platforms. Experience with data modelling and transformation techniques. Knowledge of data governance, data privacy, and security best practices.
• Desirable but not essential- Life Sciences, Pharma, Clinical or similar.
• Experience in leadership and organisational change management influence at all levels
• Demonstrated ability to influence without authority.
• Proven strength to communicate clearly and succinctly with all audiences and forums through exemplary oral and written communication skills.
• Demonstrated experience in managing pressure and conflicting demands with multiple customer groups.
• Demonstrated strength to build effective networks across functions, organisations, job levels and geographies.
• Strong interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups.
• Experience in working successfully across cultures and time zones.
• Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguity.
• Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation, and templates).

Other Information/Additional Preferences

• Strong communication skills and interpersonal skills with demonstrated ability to work in and across teams and achieve results through others.
• Ability to multitask and prioritise.
• Experience in vendor management
• Demonstrated experience in data analysis and interpretation.
• Flexibility (start / finish time daily)
• Open to potential evening shift work (Mon-Fri only)

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

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.

We Are Lilly