Sr Associate/ Manager - Pharmacoepidemiology Study Operations
Eli Lilly
Cork
Permanent
Full-time
1 month ago
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.Organisation Overview: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!Purpose:Global Patient Safety (GPS) is responsible for the management of safety information in support of Lilly marketed products and for compounds in development. Post-authorization safety studies/complex pharmacoepidemiology studies are often conducted in order to further identify, characterize, and evaluate safety outcomes which may impact the benefit-risk profile of a product. The purpose of the Associate/Sr Associate/Manager Pharmacoepidemiology Study Operations (PE Ops) role is to provide operational support in the design and implementation of pharmacoepidemiology studies. The PE Ops role will also support the development and maintenance of consistent operational processes for completing this work and other related PE project work.The primary purpose of the PE Ops role is to support the planning, contracting, execution and tracking of complex pharmacoepidemiology studies through the application of project management and 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; contributing to risk analysis and contingency plans at the project level; building and maintaining effective relationships with the pharmacoepidemiology team as well as partners involved in pharmacoepidemiology studies & other projects; effectively managing study communications; and ensuring documentation of key team information and decisions. In addition, the PE Ops role will work with Subject Matter Experts (SMEs) within GPS and non-GPS functions on department projects as appropriate.Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.Coordination of PE studies across all therapeutic areas (75%)Establish regular communication with key GPS, regulatory, business unit (BU) and affiliate personnel as appropriate for specific studies.Provide operational consultation resources, tools, and expertise as needed to support specific studies.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.Assess operational feasibility for planned PE studies, ensuring that privacy, local laws, affiliate requirements, logistical requirements and other operational elements are considered.Coordinate the development of communication plans for teams as needed.Anticipate and resolve key technical and operational problems and coordinate change management for studies and deliverables; this will require tactical understanding of all Safety Quality System & Medical Quality System requirements applicable to the GPS PE to ensure study execution is in compliance with all internal and external requirements.Adapt plans and implement appropriate changes in response to rapidly changing requirements and environment.Coordinate and facilitate the functioning of PE studies in collaboration with product specific Project Management, as required which would include tracking of study milestones.Monitor the implementation and execution of PE studies in conjunction with the BU CTM 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.Coordinate and/or facilitate team review meetings and after-action reviews both internal as well as with regulatory agencies (in conjunction with regulatory scientists) to identify process issues and strengths.Department-specific operational tasks & projects (25%)Work with Associate Director – Pharmacoepidemiology Study Ops to drive solutions leading to consistency in tracking, documenting and communicating project metrics.Identify and communicate the critical path and leading indicators of team progress and major milestones across multiple products.Contribute to resource prioritization decisions across portfolio as well as vendor selection decisions.Work closely with PE Sr Director and/or delegates to identify operational gaps & drive solutions department-wide.Build relationships with internal cross-functional customers and external TPOs involved in implementation on PE projects.Minimum Qualification Requirements:Bachelors or University degree (scientific or health-related field preferred) and 3 years clinical and/or observational research experience or relevant experience in a scientific or health-related field; or an advanced degree Applied knowledge of project management tools and processes (e.g. management of integration of scope, time, cost, quality, human resources, communications, risk and procurement) Demonstrated proficiency with MS Word, Excel and PowerPoint Demonstrated oral and written communication skills with the ability to communicate clearly and concisely to stakeholders and team members. Demonstrated problem-solving skills with the ability to recognize problems and take corrective action. Demonstrated teamwork skills with the ability to adapt to and influence diverse interpersonal styles; ability to influence and negotiate; ability to work in a rapidly changing environment. Demonstrated decision-making and ability to work through ambiguity.Other Information/Additional Preferences:Experience in Pharmacovigilance and patient safetyExperience with implementation of observational studiesProficiency in MS Teams and document management systemsEli 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
