Associate, Sr. Associate, Manager -Central Clinical Services
US: USA Remote, United States
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
$63,000 - $140,800Job Description
Overview:
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 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 Responsibilities
- Oversee direct communication and management of activities and assessments conducted by TPO staff for potential participants, and study partners, including screening, consenting and education.
- Ensure TPO deliverables for participant and partner screening and consenting are met providing oversight and guidance as needed.
- Monitor and manage the scheduling, logistics, technology and communication for participant/partner assessments, central raters, investigators, and other study-related entities including MRI centers and infusion centers, outsourced to vendors.
- Ensure vendors have all necessary study documentation and accurately enter data into applicable technology solutions.
- Make decisions that optimize the study experience for participants, partners, investigator and site staff balancing efficiency and quality.
- Prioritize daily work tasks to ensure timely and effective completion of responsibilities.
- Identify, communicate, and resolve site and study issues in collaboration with the Central Clinical Services capability, leveraging problem-solving skills and expertise.
- Serves as topic area expert, providing guidance and support to the team and stakeholders.
- Collaborate with the team to develop solutions to more complex related-study problems and drive process improvements.
- Provide oversight to vendors conducting site and partner/participant activities throughout all study timepoints, ensuring compliance and quality.
- Build and maintain strong investigator relationships with vendors, study sites, investigators and Lilly functions to enable an exceptional study experience.
Organizational Leadership and Process Improvement
- Provide feedback and shared learning for continuous improvement
- Manage tasks daily to ensure study assessments and activities are completed on time and with the highest possible quality.
- Ensure all requested and required guides are followed, documentation is maintained, and trackers/systems are up to date daily.
- Establishes relationships to enable study level work both externally and internally.
- Manage satisfaction of participants/partners through exceptional interactions of the vendors selected
Basic Requirements:
- Bachelor’s degree preferably in a scientific or health related field, 2+ years clinical research experience or relevant experience preferred
- Understanding of the overall clinical development paradigm and the importance of efficient site activation
- Applied knowledge of project management processes and skills
- Appreciation of / experience in compliance-driven environment
Additional Skills/Preferences:
- Effective communication (both verbal and written) and language skills – ability to communicate effectively up and down in the organization
- Knowledge of and ability to follow financial and legal guidelines and policies (budget and contract)
- Negotiation and problem-solving skills
- Self-management and organizational skills
- Fluent in English [Fluency in Spanish is a bonus]
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.
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Fully remote
Benefits/PerksFlexible benefits Fully remote Vacation Vacation benefits Volunteerism
Tasks- Develop solutions
- Ensure vendor compliance
- Manage participant assessments
- Optimize study experience
- Oversee communication
- Provide guidance
- Resolve study issues
Central services Clinical Development Clinical Research Clinical trials Collaboration Communication Compliance Continuous Improvement Contract Negotiation Data Management Digital devices Documentation Healthcare Influence Innovation Leadership Legal Mobile health care Negotiation Organization Organizational Philanthropy Problem-solving Process Improvement Project Management Recruitment Research Research Experience Retention Telemedicine Vendor Management Virtual trial orchestration Volunteerism
EducationBusiness Design DO Related Field
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9