Lilly

Manager/Senior Manager- Clinical Development (BB-2F18E)

Found in: Talent IN

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 39,000 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 people around the world.The Clinical Development Consultant (CDC) is responsible for the management of clinical sites being considered and/or participating in Lilly clinical trials; inclusive of site identification and qualification, the timely delivery of clinical trial enrollment in accordance with scientific objectives, timely delivery of database locks, issues management at clinical trial sites, and ensuring inspection readiness at all times for assigned therapeutic area(s) within a region/country that enables global program delivery. This is achieved by the CDC’s accountability for comprehensive site management, leveraging of information/tools to make/have informed decisions and discussions, and high quality interactions with global clinical trial sites to drive to an unparalled customer experience.The CDC is also responsible for oversight of vendor monitoring activities at clinical trial sites, including the identification, mitigation and escalation of significant findings and trends. Additional local responsibilities may be required as needed/appropriate for the local geography.Clinical Investigator ManagementAccountable for activities required at clinical trial sites and by investigators and site staff participating in Lilly trials; inclusive of site identification and qualification, enrollment planning and execution, to database lock and close outAccountable for comprehensive site management activities to ensure timely delivery of enrollment readiness, trial recruitment/enrollment and database locks; inclusive of performance management and issue mitigation, identification and resolutionResponsible for identifying potential opportunities to accelerate trial enrollment, while driving to an unparalleled clinical trial/customer experienceAccountable for the application of scientific, therapeutic area, and institutional/regional expertise to inform and ensure timely delivery of trial enrollment and quality dataAccountable for the development of strategic institutional/site relationships to optimize the delivery of clinical trial programs; including across therapeutic areas where applicableClinical Trial ManagementResponsible for the development and implementation of applicable site risk plans to ensure delivery of clinical trial enrollment commitments and database locksEnsure site and country level inspection readiness at all timesLeverage metrics to inform site/country/regional level decision makingWork with internal and external teams to remove barriers to trial execution at a site and/or country levelResponsible for understanding local treatment paradigms and standard of care to support targeted feasibility and strategic allocation of trials as requiredProvide vendor oversight for site monitoring activities at site/country levelBusiness Management and EngagementEstablishes and develops strong professional relationships with active/potential clinical investigators to expand/maintain clinical research partnership opportunities and provide an unparalleled experience for participation in Lilly clinical trials.Cross functional collaboration and partnership to ensure alignment in priorities and deliver the portfolioPerform targeted sites prospecting in alignment with portfolio strategy & priorityMaintain therapeutic and technical expertise to enable scientific discussions with the investigator and site personnelServe as an effective communication “bridge” between sites, third party vendors and LillyInfluence and challenge internal and external factors in order to improve clinical research deliveryMinimum Qualification Requirements:Bachelor's degree or equivalent in a scientific or health-related fieldMinimum of 5 years experience in the pharmaceutical industry and/or clinical research and strong working knowledge of Good Clinical PracticeTherapeutic expertise and knowledge of the clinical research landscape; ability to acquire and maintain therapeutic expertise to support portfolio needsStrong self-management and organizational skills; ability to manage workload, set personal priorities and adjust as neededDemonstrated strategic agility & broad business acumenDemonstrated leadership behaviours with ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertaintyOther Information/Additional Preferences:Strong communication (both verbal and written) and language skillsStrong organisational/planning skillsDemonstrated ability to enhance/improve customer experienceFluent in English as well as required language to conduct day-to-day businessStrong knowledge in country regulatory guidelines/requirementsStrong teamwork and interpersonal skillsDemonstrated decision-making abilityAbility to develop and apply creative solutionsTravel required (50-75%)

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