Associate Director - CTF Emerging Technology PM

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 45,000 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 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!

The Associate Director, Clinical Trial Foundations (CTF), will serve as the subject matter expert for clinical systems and/or digital health technologies supporting clinical development. In this role, you will define and execute implementation plans to deliver on the procedural requirements, strategies, integrations, improvements and shared learnings. The Associate Director is responsible for collaborating with business partners to enable development, implementation and support of streamlined, clear and compliant systems to support clinical development. This role will specifically be focused in the Emerging Technologies space, including, but not limited to the support of technology support model and capabilities.

Primary Responsibilities:

 Clinical Information Systems Expertise

• Understand business strategies, data flow, 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 these systems

• Support internal audits and external inspections

• Identify key functional capability gaps early enough to help ensure robust processes in place to meet team needs and/or manage expectations to avoid downstream delivery delays

• Introduce efficiencies into the technical landscape.

Project Management

• Define, lead and execute implementation plans to deliver on procedural requirements, technology strategies and improvements

• Coordinate development of Fit For Purpose plan. Research proposed technologies.

• Challenge plans/dataflow for infusion of best practices into clinical research.

• Conduct shared learning sessions and be a strong voice at that table.

• Develop critical success factors for pilots/projects and monitor progress to ensure clear criteria exists to enable decision making

• Identify, monitor and communicate global customer (internal and external) needs/requirements related to process and/or technology performance and improvements

• OCM - partner cross-functionally for interoperability. Lead organizational change, communication planning and training initiatives.

• Identify project implementation and system execution risks and raise issues appropriately

• Lead progress reporting activities and system metrics to leadership, process owners and end users

• Routing documents in Quality Docs; filing of documentation in eTMF; catalog migration

Partnership

• Partner with process owners, leadership, Quality and Information Technology to ensure capable, integrated and efficient system usage across the portfolio

• Lead Visit 2, Visit 3 ETF assessments

• Actively drive in shared learning across the team

• Work with vendors to improve customer experience and efficiencies

Minimum Requirements:

• Bachelor’s degree preferably in science, IT or health related field, or equivalent work experience preferred.

• 5 – 8 years experience with at least 3 years in medical, clinical data management, clinical drug development, or clinical information flow

• Digital/Technical Literacy. Pharma experience. GCP-Clinical Trial Regulations Fluency.

• Communication excellence. Excellent oral and written communication skills; able to communicate clearly and succinctly with team members and leadership.

• Critical thinker. Strong problem-solving skills; able to anticipate and recognise problems, diagnose root causes and take corrective action to prevent recurrence within the team.

• Team Player with demonstrated ability to lead large projects, cross functional influence and decision making (depth and breadth of expertise)

• 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:

• Experience in clinical development systems as well as current and evolving technologies to support clinical development and clinical data management

• Knowledge and/or experience in project management and organizational change with Lilly staff and external parties including vendors, industry experts and related organizations

• Good interpersonal and leadership skills

• Excellent oral and written communication 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 positively handling and resolving conflict

• Flexibility in approach; able to adjust to unexpected business opportunities while also being a catalyst for change

• Knowledge of regulatory and quality requirements governing clinical development

• 10% or less travel

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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

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