• Proactively collaborate with initiative leads and management to prepare, organize, coordinate, document and/or provide the development and delivery of department products and services to a globally dispersed, cross-functional audience in support of business outcomes and industry compliance requirements. • Develop varied support materials, presentations, and/or tools to support department's remit and strategies. • Proactively collaborate with initiative leads and management to develop, optimize and improve processes, associated systems/applications, training and communications. • Lead small to medium-scale process improvement initiatives. • Develop process improvement processes and solutions. • Identify and collate information required to assess compliance with processes and to prioritize business process improvement needs. • May review, assess and update procedural documents for overall compliance with current processes. • Perform special projects, assignments and administrative tasks per business needs. • Provide training and guidance to junior team members

Associate Director - Clinical Research Lead-Oncology (Minnesota, Illinois, Wisconsin, Iowa) locations US, Remote time type Full time job requisition id R-101931 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.   Purpose: The Clinical Research Lead (CRL) is a strategic, field-based scientific leader responsible for driving the execution of Lilly clinical trials through exceptional investigator engagement and site performance management. This role is pivotal in ensuring Lilly’s portfolio is prioritized at high-performing sites and that trials are delivered with quality, speed, and insight. CRLs combine deep therapeutic and scientific knowledge with strategic agility to influence investigators, elevate protocol understanding, and co-develop tailored enrollment strategies in existing and new therapeutic areas. They serve as trusted partners to investigators—building strong, enduring relationships that improve return on enrollment and position Lilly as the sponsor of choice. CRLs partner closely with internal Lilly teams (including Clinical Development and Medical Affairs) to ensure that insights from the field shape development strategies and that development strategies are delivered with operational excellence and scientific clarity. Where applicable the CRL may also represent Investigator Engagement with Regulatory and External Bodies and help shape the country-level clinical trial landscape.   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. Clinical Investigator Management - Accountable for the full spectrum of investigator engagement from identification and qualification through enrollment, and support database lock, and study closeout - Serve as a clinical trial scientific ambassador, ensuring investigators deeply understand protocol intent, scientific rationale, and patient eligibility requirements - Develop and sustain strategic, high-trust relationships with investigators that span trials and therapeutic areas - Influence enrollment by co-creating tailored recruitment strategies aligned with site capabilities, patient population realities, and study objectives - Proactively find opportunities to reach new patients, accelerate enrollment and increase impact at priority sites, including for example, novel site models, community-based research initiatives etc - Capture and elevate critical insights from sites to optimize feasibility, protocol design, and study conduct   Clinical Trial Management - Lead site-level strategy and risk planning to ensure strong and predictable enrollment and data delivery - Leverage performance metrics to anticipate issues, intervene decisively, and maintain momentum toward clinical milestones - Drive inspection readiness as a continuous discipline across sites - Collaborate across functions and with vendor partners to resolve operational barriers, ensuring delivery with speed and quality - Maintain advanced understanding of local treatment paradigms and standard of care to influence strategic country/site selection and protocol localization - Provide oversight and quality assurance for vendor monitoring, escalating risks proactively - Where applicable, lead end-to-end management of Post-Marketing Safety Studies in compliance with local regulations   Business Management and Engagement - Cultivate a portfolio of strategically aligned, high-impact investigators who consistently prioritize Lilly trials - Enable an exceptional investigator experience by being a responsive, knowledgeable, and valued scientific partner - Collaborate cross-functionally (e.g., Medical, Clinical, Study Delivery) to align on trial and site priorities, troubleshooting challenges with urgency and creativity - Conduct data-informed site prospecting and prioritization, contributing to trial competitiveness and regional strategic execution - Maintain scientific fluency and therapeutic expertise to lead meaningful, solutions-focused discussions with site personnel - Act as a key liaison between field teams, vendors, and investigators, ensuring alignment, shared purpose, and continuous knowledge transfer - Partner closely with field team colleagues to elevate the investigator and site experience, ensuring seamless collaboration and improving enrollment outcomes and Investigator relationships   Country / Regulatory Engagement (where applicable) - Represent Investigator Engagement with regulatory agencies, ethics committees, and national research organizations in countries/territory - Influence the clinical trial ecosystem to improve regulatory agility and operational feasibility - Ensure that local requirements are translated into compliant, efficient trial execution and that Lilly’s internal processes reflect evolving country landscapes - Partner with leadership to identify and align regional initiatives and contribute to enterprise-wide clinical development success   Minimum Qualification Requirements: - Bachelor’s degree or equivalent; strong preference for scientific, clinical, or health-related fields - Minimum 5 years of experience in clinical research or pharmaceutical industry with experience directly interacting with or working with HCPs and clinical sites - Minimum 2 years of relevant clinical or therapeutic area experience in Oncology - Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g. H-1B or TN status) for this employment position - Currently reside in or be willing to relocate to our designated Midwest region (Minnesota, Illinois, Wisconsin, Iowa)   Other Information/Additional Preferences: - Advanced degree in a scientific or clinical field (PharmD, PhD, MD, or MSc preferred) - Excellent understanding of GCP, clinical development and operations, and trial lifecycle - Demonstrated understanding of the therapeutic landscape and standards of care, with the ability to apply this knowledge to decision making - Proven ability to build credibility and influence HCP community through scientific acumen and relationship strength - Strategic approach with demonstrated success in delivering results in complex, fast-paced environments - Data-driven decision-making skills; ability to interpret and act on performance and operational metrics - Excellent communication, negotiation, and organizational skills - Deep therapeutic area knowledge and familiarity with local clinical research ecosystems - Experience directly influencing clinical site performance and driving enrollment success - Track record of delivering or exceeding performance targets in a collaborative matrix environment - Experience working with regulators or national bodies in support of clinical trial delivery - English fluency and proficiency in local language(s) as needed   Travel Requirements: - Willingness to travel extensively (60-80%) 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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.   Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is $115,500 - $204,600   Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.   #WeAreLilly

• Oversee the clinical portion of the budget to ensure efficient resource allocation. • Develop monitoring plans and tools, ensuring effective study oversight. • Train and mentor Clinical Research Associates (CRAs) to optimize their performance. • Drive enrollment and lead study start-up activities, adhering to timelines. • Review trip reports and implement corrective and preventative action plans when necessary. • Foster productive relationships with Sponsors, vendors, and cross-functional teams.

Role Description The Operations Specialist - Medical Information- 100% remote will review, assess, and process safety data from multiple sources, ensuring accurate case handling and timely distribution of reports to internal and external stakeholders. All activities must follow global regulations, SOPs, and project‑specific guidelines, with support from senior team members. - Process and triage safety data according to regulations, SOPs, and project requirements. - Collect, track, and assess incoming adverse events, determining initial vs. follow‑up status. - Perform database entry, MedDRA coding, narrative writing, and literature surveillance. - Maintain quality and productivity standards while ensuring full compliance with all procedures. - Create, update, and track cases according to project plans. - Identify and escalate quality issues to senior team members. - Collaborate with cross‑functional teams (project management, clinical, data management) and healthcare professionals (investigators, medical monitors, site staff). - Communicate with clients regarding day‑to‑day case processing when required. - Support onboarding and mentoring of new team members when assigned. - Participate in team meetings, audits, and inspections. - Contribute to departmental initiatives and maintain 100% compliance with people processes. - Depending on project needs, perform medical review of non‑serious AEs/ADRs, including coding checks, medical history review, concomitant medications, expectedness, causality assessment, and documentation. Qualifications - Bachelor’s degree in a scientific, healthcare, or life‑science field. - Up to 3 years of experience in pharmacovigilance or equivalent training. - Advanced English required. - Strong knowledge of medical terminology and global safety regulations. - Experience with safety databases and client/internal applications. - Excellent attention to detail, accuracy, and quality standards. - Proficiency in Microsoft Office and web‑based tools. - Strong organizational and time‑management skills. - Ability to work independently, follow guidelines, and manage multiple priorities. - Strong teamwork skills and ability to build effective working relationships. - Ability to work shifts and travel occasionally if required. Company Description IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.