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.Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is$111,000 - $162,800Overview:At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.Purpose:The Clinical Central Services and Innovation (CCSI) organization is responsible for strategically planning and supplying materials, trial support services and innovative capabilities to support the execution of clinical trials globally for all business units across all phases of development. This group is within the Clinical Capabilities organization and partners across functions within the CDDA and PRD to influence trial design and provide solutions to operationalize these trials and enable asset strategies across the portfolio.The Associate Director of CCSI is focused on delivering the implementation of clinical capabilities including but not limited to mobile health care, telemedicine, virtual trial orchestration, recruitment & retention, new site models, central services and/or digital devices. This role will also be responsible for vendor management to support the capabilities.Responsibilities:Central Clinical Services
Oversee vendor operations to ensure effective communication and management of activities and assessments for potential participants, participants, and study partners.
Ensure vendors deliver education and manage study participant and partner screening and consenting.
Supervise vendors in initiating and managing all assessment scheduling, logistics, technology, and communication for participant/partner, central raters, investigators, and other study-related entities including MRI centers and infusion centers, where applicable.
Ensure vendors maintain all study documentation and data entry into applicable technology solutions.
Contribute to process optimization
Lead decisions across studies and across vendors that impact Central Clinical Services operations.
Make decisions in the best interest of the participant, partner, investigator and/or other site staff to drive improved experiences and optimal efficiency.
Serves as Central Clinical Services expert and influences complex business and technical decision and process improvements.
Oversee the vendor partner day to day operations and provide coaching and training, as necessary.
Provide expertise related to budget processes and identify strategic levers to obtain cost savings and efficiency gains.
Actively manage trial, country and site-level tasks ensuring all study assessments are completed with the highest quality and within protocol parameters.
Coordinate financial responsibilities including purchase order creation, invoice management, study-specific center payments and payment reconciliation.
Build and maintain relationship with study participants to enable exceptional study experience; build and maintain relationship with research team (PI, central raters, etc.)
Develop and implement methods, mechanisms, and tools to meet and measure investigator, participant, partner, and vendor satisfaction
Monitor site contacts (e.g., calls, written communication, etc.) and KPIs (key performance indicators), to ensure CCS is in accordance with Lilly Standards (Patient Safety, Medical Quality, privacy etc.) and external and regulatory requirements.
Generate, revise and train CCS team on site documents (e.g., operational manual, FAQ document, etc.)
Organizational Leadership and Process Improvement
Influence vendors to develop strong partnerships with Participants, Partners, Investigators, and other site staff. Manage internal relationships across the CDDA (Trial Capabilities, Investigator Engagement, Patient Engagement, Clinical Design, Clinical Development, Asset Team, CCSI, CLS, SD&A)
Lead and be a resource for others on local regulations, laws, and guidance (e.g., FDA, ICH), Quality and Business Systems, and Good Clinical Practices (GCP) to achieve inspection readiness and detect and resolve quality issues.
Apply problem-solving skills and effectively partner with institutions, investigators, and cross-functional study team to resolve issues ensuring solutions meet regulatory and ICH/GCP requirements.
Manages ethics review board interactions; interacts with auditors; supports inspections; creates and maintains strong investigator relationship.
Create, communicate, and execute site and country level risk mitigation and contingency plans.
Basic Requirements:
Bachelor’s degree in a scientific field or health-related field
5 years’ experience in Clinical Trials/Development and good working knowledge of Good Clinical Practice
3+ years’ experience in working with and managing CROs or external vendors for the execution of clinical trials
Additional Skills/Preferences:
Demonstrated leadership skills with ability to influence, achieve results through others and lead across the business and across regions/geographies
Experience in supervision, coaching and mentoring others
Demonstrated business acumen (financial oversight, business development, business planning)
Effective communication (both verbal and written) and language skills – ability to communicate effectively up and down in the organization
Strong organizational/planning skills
Fluent in English [Fluency in Spanish is a bonus]
Knowledge of country regulatory guidelines/requirements for clinical research conduct
Strong interpersonal skills
Demonstrated decision-making ability
Ability to develop and apply creative solutions
Experience in working cross-culturally and with virtual teams
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 an EEO/Affirmative Action Employer and 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.Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.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