Senior Associate/Manager – Clinical Trial Product Owner

Job title:

Senior Associate/Manager – Clinical Trial Product Owner

Company

Eli Lilly

Job description

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 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, Investigator Engagement, Clinical Development and Design, Statistics, portfolio deliver teams, Clinical Innovation, Clinical and Laboratory Data Sciences, organizational leadership, Quality and Tech@Lilly to deliver product enhancements and improvements across multiple functions. This role will partner with CDDA leadership on Master protocol strategy to deliver new capabilities.Primary ResponsibilitiesSystem Technology and Process Implementation

• Serve as domain expert to drive the application and integration of functionality across the technology platform to deliver value in assigned area, with quality, on time, on budget and within scope.
• Anticipate and proactively address technical challenges and navigate resolution to ensure quality product and maintain program timeline.
• Prioritize and manage product backlog items to maintain lifecycle management.
• Define, lead, and execute implementation plans to deliver on technology strategies and improvements.
• Identify project implementation and system execution risks and raise issues appropriately.
• Develop & monitor critical success factors for pilots/projects and report progress to ensure clear criteria exists to enable decision making.
• Drive and support Impact assessments cross functionally.

Technology Adoption

• Act as the main point of contact between product technology teams and stakeholders.
• Define and design enhancement requirements and design documents.
• Conduct User Acceptance Testing (UAT) and Regression testing.
• Maintain and grow expertise in clinical information systems & business strategies, processes and technology as it relates to clinical development.
• Identify, monitor, and communicate global customer (internal and external) requirements as related to process and/or technology performance and improvements.

Communication

• Coach and train others as needed, to ensure the effective implementation and adoption of technology product.
• Lead organizational change, communication planning, and training initiatives related to the adoption and implementation of business functions.
• Maintain and grow expertise in clinical information systems & business strategies, processes and technology as it relates to clinical development.
• Provide guidance and consulting to forecasting expenses.
• Lead and deliver progress reporting activities and system metrics to leadership, process owners and end users.
• Partner with process owners, leadership, Quality and Tech@Lilly to ensure capable, integrated and efficient system usage across the portfolio.

Minimum Qualification Requirements

• Bachelor’s degree preferably in science, IT or health related field, or equivalent work experience preferred.
• In-depth knowledge/experience in medical, quality, clinical drug development, or clinical information flow is 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.
• Strong strategic planning skills.
• Flexibility to adjust quickly and effectively to frequent change and altered priorities.

Additional ResponsibilitiesAdvanced degree, in technology or science- or health-related fieldPrevious working experience as a product owner.Previous experience with business management processes, quality systems, process management.Previous experience leading implementation of emerging technology, automation, system changes or upgrades.Demonstrated influence with peers, leadership, and stakeholder groups across functional boundaries.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.Demonstrated strength in logical thought, problem solving ability and critical thinking.Ability and experience in building consensus and resolving conflict to drive progress.Proven ability to synthesize information from multiple sources, understand root causes, and make risk-based decisions.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 developmentLimited travel, including international, up to 10%Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.#WeAreLilly

Expected salary

Location

Cork

Job date

Sat, 01 Jun 2024 22:09:55 GMT

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