OverviewAt 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.At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.PurposeThe Clinical Development Trial Lead (CDTL) Associate leads the cross-functional study team in the development and execution of clinical trials and is accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. The CDTL Associate leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables.Primary ResponsibilitiesThis job description provides 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.Trial Leadership and Regional Operational KnowledgeUse processes and tools to develop, execute, and deliver local, regional and/or global clinical trials.Scope: Understand the scope of work required to complete the clinical trial successfully. Monitor status and make changes per change control to meet deliverables.Timeline: Develop and track global milestones by gaining alignment and integrating inputs across functions and geographies.Risk: Assess, identify and monitor trial-level risks. Create an integrated trial-level risk mitigation and contingency plan.Budget: Understand cross-functional, trial-level budget components. Create and monitor grants and non-grants, and assumptions using financial tracking tools. Network with appropriate business partners on budget status and changes.Partner with other organizations to coordinate and deliver Investigator Study Specific Training (ISSTs)/Affiliate Study Training (ASTs)/Investigator Engagement Meetings.Drive and coordinate local, regional and global cross-functional study teams through study implementation, execution and closure, enabling them to meet deliverables, including issue management, contingency planning and resolution.Be accountable for trial/regional enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET).Partner with the Investigator Engagement organization to achieve regional enrollment goals.Manage relationships and serve as a single point of contact for trial communication to and from the Clinical Design and Delivery organization, cross-functional team members, and Third Party Organizations (TPOs).Apply problem-solving skills to daily issues with cross-functional study teams (including vendors, affiliates/regions, global team members, and other partners).Identify and assist in developing continuous improvement activities based on industry, regulatory, and new technology trends.Manage TPO qualification, selection, and oversight.Clinical Trial Process Leadership and ExpertiseDemonstrate understanding of the drug development process and the inter-relatedness of cross-functional activities; identify opportunities to deepen clinical trial process expertise.Be knowledgeable of the global and regional operating model; coordinate and facilitate obtaining regional input for study teams.Serve as single point of accountability for the Trial Master File, ensuring the file is current and inspection-ready at all times.Anticipate trial and regional issues, identify process breakdowns, assess situations and propose proactive approaches to mitigate risks affecting delivery.Demonstrate ability to lead and influence amid ambiguity.Coach peers, cross-functional team members and TPOs on clinical trial processes and regional specifics.Apply knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards; liaise with affiliates to understand local regulatory requirements.Scientific ExpertiseProvide technical consultation for clinical and regulatory documents; prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.Combine scientific knowledge with clinical trial operations to impact trial design, feasibility, implementation, and execution.Use clinical development knowledge and problem-solving to support scientific needs of the business and clinical programs.Minimum Qualification RequirementsBachelors or University degree (scientific or health-related field preferred) and 3 years clinical research experience or relevant clinical trial experience in a scientific or health-related field; or an advanced degree.Highly Desired SkillsApplied knowledge of trial execution methodology, processes, and toolsDemonstrated ability to work cross-culturally with global colleagues and with TPOsAbility to influence without authorityStrong leadership and networking skills in cross-functional and cross-cultural teamsEffective communication, self-management, and organizational skillsProblem-solving, critical thinking, and ability to navigate ambiguityFlexibility to adjust to altered prioritiesOther Information/Additional PreferencesNeed to travel periodically to AST/ISST/Investigator Engagement meetings and potentially other scientific or regional symposiums. Note: When applying internally for a position your current supervisor receives notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying. 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. #WeAreLillyLilly 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 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. #WeAreLillyUKandIreland
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