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.

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, 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. 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!

Overview

The Pharmacoepidemiology Project Manager (PEPM) leads the cross-functional study team in the development and execution of pharmacoepidemiology (PE) trials and is accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. The senior PEPM Manager/Lead leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables.

The primary purpose of the GPS PEPM is to support the planning, contracting, execution and tracking of complex PE studies through the application of project management and expert knowledge in PE studies. This includes supporting teams on the delivery of cross-functional initiatives and projects, accountability for delivery of project milestones through the utilization and development of project management tools, processes and standards; developing risk analysis, implementation and contingency plans at the project level; influencing operational best practices across the PE department; building and maintaining effective relationships with the PE team as well as partners involved in PE studies & other projects; effectively managing upward and cross-functional communications; and ensuring documentation of key team information and decisions. The PEPM will work with Subject Matter Experts (SMEs) within GPS and non-GPS functions on department projects as appropriate.

Primary Responsibilities:

1. Strategic Leadership & Portfolio Oversight

Lead the planning, execution, and delivery of a diverse portfolio of PE studies.
Provide strategic input on epidemiologic study design, feasibility, analytic approaches, and data source selection.
Ensure alignment of study strategy with regulatory requirements, product safety needs, and business objectives.
Understand the PE study commitments across a molecule to ensure solutions meet the needs of the molecule by delivering a committed trial.
Collaborate with the PE scientist to align on the operational strategy to successfully implement the trial strategy.
Partners with Regulatory and PE scientists/leadership on PMR/PMC dates to ensure dates are achievable. This includes an evaluation of like trials ran by PE historically to assess ability to meet timelines prior to regulatory commitment.
Partners with the PE scientists, GPS Medical Leadership to ensure the Trial strategy, Molecule Strategy and Cross-Molecule Strategy meets the needs of the organization with a focus on cost, time and resource management to ensure on time or early delivery that meets or regulatory obligations with minimal protocol amendments.
Manages the Study Management Team meetings and ensure aligned communication across functions and stakeholders.
Assess the needs for master protocols vs. Individual trial protocols based on the similarity of trials at the molecule level as well as across molecules to ensure strategic delivery is achieved and is optimized.
Makes recommendations to PMO leadership on CRO synergies, CRO delivery escalations, that limit internal resource needs and leverages CRO capabilities.
Ensures data accuracy across tracking systems for studies to ensure accuracy at the portfolio level.
Promote a culture of scientific integrity, transparency, and operational excellence.

2. Project & Program Management

Oversee end-to-end program management for internal and outsourced PE studies, including timelines, budgets, risk mitigation plans, and resource allocation.
Implement best-practice project management frameworks, governance models, and quality standards.
Ensure deliverables meet scientific, operational, and compliance standards.
Provides consultation for clinical and regulatory documents such as study protocols, Investigation Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, study reports, abstracts, and publications
Initiates confidentiality disclosure agreements (CDA’s) as needed with outside consultants and vendors

3. Vendor Management & Oversight

Lead the selection, oversight, and performance management of external vendors/CROs executing observational research.
Manages CDA’s.
Liaise between PE scientists and Research and Development Operations (RD Ops) /Procurement/ Quality in the contracting of PE studies to external vendors to ensure cross-functional communication and overall coordination in the development of RFPs, identification of TPOs, creation of resourcing requests, and advising on scope of work for determining quality assessment requirements.
Manage relationships and serve as a single point of contact and central owner for trial communication, to and from GPS Medical, Business Unit, TPOs.
Manage TPO qualification process, selection, and oversight.
Partner with procurement to ensure contract language contains trial milestones for payment, clear timelines and penalties for missing timelines, underperformance or lack of over delivery. Contracts must contain service level agreements tied to milestone payments and Key Performance Indicators for CRO and study management.
Escalate issues to joint operations for management and resolution.

4. Regulatory & Compliance Responsibilities

Ensure all studies meet regulatory expectations (e.g., EMA PASS, FDA PMR/REMS, GVP Module VIII) and internal quality standards.
Contribute to regulatory submissions, safety updates, study protocols, and responses to regulatory queries.
Stay current with evolving epidemiologic methods, RWE guidance, and data governance requirements.
Support audit and inspections in the back room/front room.
Contribute to regulatory responses/submission by leveraging the SMT to provide requested information that is accurate and timely.

5. Clinical Trial Process Leadership

Apply problem-solving skills to daily issues with cross-functional study team (including with vendors, affiliates/regions, global team members and other business partners).
Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
Manage TPO qualification process, selection, and oversight.
Enter key milestones into the dedicated tracking system (i.e., Pangea, Prism, Veeva Clinical).

6. Study Management

Leads the kickoff meeting for new trials and establishes the Study Management Team.
Initiate Study Management Team meetings. Identifies the functional representation (Regulatory, data management, medical, As Promo, BU, etc.). Manages the Agenda, tracks issues and action items to closure. Ensure meeting minutes are captured and filed to show internal and CRO oversight of the trial from start to finish.
Consults internal partners (Business Units, Ad Promo, etc.) for review of websites, recruitment materials, and labeling updates.
Assess operational feasibility for planned PE studies, ensuring that privacy, local laws, affiliate requirements, logistical requirements and other operational elements are considered.
Monitor the implementation and execution of PE studies in conjunction with the BU and GPS quality group and execute interventions necessary to ensure attainment of milestones and deliverables; this would include applicable internal documentation of appropriate GPS oversight.
Partner with cross-functional team to facilitate the trial protocol development and maintenance process.
Demonstrate understanding of drug development process. Acknowledge inter-relatedness of cross functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise.
Be knowledgeable of the global and regional operating model; coordinate and facilitate obtaining regional input to provide to the study teams.
Single point of accountability for the Trial Master File, working closely with functional record owners to ensure the file is always current and inspection ready.
Network and leverage expertise to anticipate trial and regional issues, identify areas of process breakdown, assess situations and propose proactive approaches that reduce and/or mitigate risks that impact ability to deliver the clinical trial.
Demonstrate ability to lead and influence during ambiguity.
Coach peers, cross-functional team members and TPOs on aspects of clinical trial process and regional specificities.
Report, manage and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools from study implementation through closure.
Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of clinical trials. Liaise with affiliates and other appropriate resources to understand local regulatory requirements.
Drive and coordinate local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution.
Be accountable for trial/regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET).
Partner with Regional Operations to achieve regional enrollment goals.

7. Leverage Scientific Expertise in Trial Delivery

Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.
Combine scientific regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation.
Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.

Transferrable Skills Application in Daily Work:

Requires business and technical knowledge within discipline and understanding of key business drivers.
Makes decisions within guidelines and policies.
Educates self and others on complex issues and gains support for ideas.
Provides sound problem-solving skills to complex issues.
Has impact within related departments or areas.
May lead small to medium projects or programs with minimal to moderate risks and resource/financial requirements.
Anticipates customer needs and handles non-standard requests.

Minimum Qualification Requirements:

Bachelor's degree in a scientific or health related field.
Minimum 5 years clinical research or relevant experience.
Strong leadership and networking skills.
Strong communication skills.
Demonstrated problem-solving abilities.
Strong self-management, organizational and interpersonal skills.
Strong verbal reasoning, attention to detail, critical thinking, problem solving, and analytical abilities.
Previous experience working in cross-functional teams or projects.
Ability to travel (up to 10% expected – varies dependent on responsibilities)

Highly Desired Skills:

Applied knowledge of project management methodology, processes and tools.
Demonstrated ability to work cross-culturally with global colleagues and with TPOs.
Ability to influence without authority.
Strong leadership and networking skills exhibited while working in cross-functional and cross-cultural teams (internal & external) and on projects.
Effective and influential communication, self-management, and organizational skills.
Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguity.
Solid self-management and organizational skills.
Flexibility to adjust to altered priorities.

Other Information/Additional Preferences:

Prior clinical trial site-level or affiliate experience.
Proficiency in use of project management tools and techniques (e.g., PMI, Critical Chain, ProChain Enterprise, MS Project, MS Excel, MS PowerPoint).
Need to travel periodically to AST/ ISST and potentially other scientific/ regional meetings.

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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Associate, Sr. Associate, Manager Pharmacoepidemiology Project Manager (PEPM)

Benefits

Job Description