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 Senior Manager Trial Capabilities leads the clinical trial capabilities in support of clinical development. In this role, the Sr Manager is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out . The Senior Manager is accountable for the prioritization, planning and implementation of site initiation activities working closely with the clinical functions at the affiliate, global study teams and other global clinical functions ensuring accurate planning, prioritization and timely execution to meet portfolio needs.
The Sr manager provides leadership, direction and technical support to Trial Capabilities focusing on results and driving efficiency to achieve goals and objectives. The Sr Manager will ensure inspection readiness at all times through a complete, accurate and readily available Trial Master File (TMF) as per defined TMF document ownership.
Primary Responsibilities:
Clinical Trial Capabilities Responsibilities
Accountable for meeting and exceeding goals for clinical trial initiation for development programs in the country.Accountable for ensuring site initiation and maintenance activities comply with local/regional requirements, data privacy requirements and Lilly quality standards.Effective communication and negotiation of budget and contract management.Effective oversight on managing investigator payments and any other financial transactions related to Trial Capabilities which include, but not limited to, vendor creation and management, purchase order creation and maintenance, payment activities, country/site budget tracking, and payment-related issue resolution.Drive and ensure site activation strategies are created and delivered.Manage communications/relationships and serve as the point of contact for the trial capabilities deliverable representing progress to business partners.Accountable for prioritization of work to meet portfolio needs.Ensure flexibility of resources across trial capabilities teams and geographies.Provides expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements.Develop and manage strategies to improve customer experience.Ensure inspection readiness through a complete, accurate and readily available Trial Master File.Strategic prioritization and use of internal system to ensure accuracy of trial/site performance.Accountable to audit and inspection responses and corrective action plans that under the responsibility of Trial Capabilities.Understand, comply, and reinforce local regulations and guidance, Lilly Medical policies and procedures, and Good Clinical Practice (GCP).Organizational Leadership
Identify and ensure shared learning across the clinical capabilities organization and with other functional groups within the CDDA.Build capabilities in the function through the development and improvement of processes, tools and training and partnering with other CDDA functions to leverage technology to increase efficiency of clinical trial capabilities and resources.Enable a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning.People Management and Development
Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in clinical development.Effectively manage an agile organization that continuously meets the needs of a changing portfolio.Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment based decision making in clinical delivery.Minimum Qualification Requirements:
Bachelor’s degree preferably in a scientific or health related field, five years clinical research experience or relevant experience preferred.Additional Requirements:
Understanding of the overall clinical development paradigm and the importance of efficient site initiation.Previous supervisory experience.Strong leadership skills and ability to influence others and lead across the business.Project management processes and skills.Appreciation of / experience in compliance-driven environment.Ability to learn and comply with financial and legal guidelines and policies (budget and contract).Effective communication, negotiation, and problem-solving skills.Self-management and organizational skills.Language capabilities – English (read, write, conversation) and local language, as applicable.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 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.
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