Sr. Associate/Manager - Clinical Systems Management

at  Lilly

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.
At Eli Lilly Cork, 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 41,000 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 patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 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, Age & Culture, LGBTQ+ 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!
Clinical Trial Foundations (CTF) as part of Clinical Design, Delivery & Analytics (CDDA) provides leadership in the strategy and development of contemporary clinical trial processes, technologies, information, and capabilities and in shaping external policy and guidance to speed the delivery of medicines to patients globally. The Clinical Systems Management role will support systems used in the management of clinical trials. The role will be based in the Global Business Solutions (GBS) center in Cork, with daily functional interactions with the wider team in the US. Working closely with colleagues in CDDA, Tech@Lilly, and other components of the R&D organization, the Clinical Systems Management role will help deliver the operational, compliance, and quality status of prioritized CDDA business system support. This role will also assist with functional area business and Tech@Lilly processes related to the development and lifecycle management of these systems, including data information & migration services. This role will be initially focused within the decentralized trials research enablement space, including, but not limited to the implementation and maintenance of novel patient recruitment and enrollment systems. Project management, business analysis, along with some programming and/or validation skills will be essential to success in this role.

MINIMUM QUALIFICATION REQUIREMENTS

• Bachelor’s degree preferably in Computer Science or IT, or equivalent work experience, preferred.
• Applied experience in medical, quality, clinical drug development, or clinical information flow, preferred
• Excellent oral and written communication skills; able to communicate clearly and succinctly with team members and leadership.
• Strong problem-solving skills; able to anticipate and recognize problems, diagnose root causes and take corrective action to prevent recurrence within the team.
• Excellent self-management and organizational skills; able to manage workload, set personal priorities and adjust as needed.
• Flexibility to adjust quickly and effectively to frequent change and altered priorities.

• Maintain and grow a strong working knowledge of the various systems used across CDDA in clinical trials.
• Use expertise in business process understanding, development and support, to manage CDDA business systems.
• Provide technical knowledge and help with the coordination of all CDDA business system support, maintenance, and deployment activities.
• Provide as needed support for the timely installation of new releases and patches by providing technical expertise, associated training, and business process development.
• Resolve system issues quickly to ensure continued access; apply root cause analysis as needed.
• Provide support to system users with queries and incidents in line with agreed Service Level Agreements.
• Identify system risks and issues and raise concerns appropriately.
• Apply knowledge and experience to continuously improve functionality and efficiency.
• Partner across functions, geographies and vendor staff as needed.
• Understand and respond to customer feedback on systems.
• Manage user access to relevant systems ensuring that users have met the access requirements.
• Support system testing as needed.
• Support internal audits and external inspections as needed.
• Develop and support user training as needed, including maintenance of job aids, FAQs, knowledge base, etc.
• Complete data movement activities and associated quality checks.
• Develop and maintain metrics as needed.