Associate/Sr. Associate – CTF - Trial Management Systems

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, 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 Trial Management Systems role will   support clinical data system development. The Trial Management Systems role will execute implementation plans to deliver on the system strategies, integrations, and improvements for clinical data management systems. The Trial Management Systems role is responsible for collaborating with internal and external business partners to enable development, implementation, and support of streamlined, clear and compliant systems to support clinical development and operations.

This role will collaborate with Process Owners, CDDA leadership, Trial Capabilities, Site Engagement, Clinical Innovation, Clinical and Laboratory Data Sciences, organizational leadership, Quality and Tech@Lilly to deliver business and customer-focused, efficient clinical data systems.  This role will partner with our vendor companies who are responsible for delivering these capabilities/systems. 

Responsibilities

• Maintain and grow expertise in clinical information systems & business strategies, processes and technology as it relates to clinical development.
• Serve as domain expert to ensure data, process and/or technology interfaces are optimized across other clinical information systems that are integrated with Veeva Vault Clinical Platform.
• Support internal audits and external inspections.
• Define, lead, and execute implementation plans to deliver on technology strategies and improvements.
• Develop & monitor critical success factors for pilots/projects and report progress to ensure clear criteria exists to enable decision making.
• Identify, monitor, and communicate global customer (internal and external) requirements as related to process and/or technology performance and improvements.
• Lead organizational change, communication planning, and training initiatives related to the adoption and implementation of VC functions.
• Provide guidance and consulting to forecasting expenses.
• Identify project implementation and system execution risks and raise issues appropriately.
• Lead and deliver progress reporting activities and system metrics to leadership, process owners and end users.
• Partner with process owners, leadership, Quality and IDS to ensure capable, integrated and efficient system usage across the portfolio.
• Actively participate in shared learning across the team.
• Work with vendors to improve customer experience and efficiency.

Basic Requirements

• Bachelor’s degree preferably in science, IT or health related field, or equivalent work experience preferred.
• 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.
• Strong interpersonal skills.
• Flexibility to adjust quickly and effectively to frequent change and altered priorities.

Additional Preferences

• Advanced degree in relevant field.
• Experience in clinical development data systems as well as current and evolving technologies to support clinical development.
• Knowledge and/or experience in project management and organizational change with internal and external parties including vendors, industry experts and related organizations.
• Good leadership skills.
• Strong business insight.
• Demonstrated strength in logical thought, problem solving ability and critical thinking.
• Ability to communicate and influence across functional boundaries.
• Ability and experience in building consensus and resolving conflict to drive progress.
• Flexibility in approach and/or high learning agility.
• Ability to adjust to unexpected business opportunities while also being a catalyst for change.
• Knowledge of regulatory and quality requirements governing clinical development.
• Limited travel, including international, up to 10%