Associate / Sr. Associate - Clinical Development Trial Lead
Eli Lilly
Cork
Permanent
Full-time
20 days ago
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.At Lilly, we make a difference for people the world over by discovering, developing and delivering medicines that help people live longer, healthier and more active lives. Central to all that we do are our talented and motivated professionals, circa 800 of whom are based at our Global Business Solutions centre in Little Island, Cork. There we boast vibrant workforce made up of over 44 nationalities, speaking over 27 languages.Established in 2010 to gain efficiencies in areas such as General Accounting, Purchase to Pay and Order to Cash, the GBS Cork quickly excelled in its financial mandate, allowing the Cork leadership to ask, how can we apply these processes to other areas of the business? And so the GBS we have today was born, still leading in finance, but also evolving and expanding into diverse Business Service functions including Customer Meeting Services, Global HR Data Management, Medical Information, Procurement, Trail Capabilities, Global Scientific Communications and more to come on stream across 2020.This, along with the physical expansion of the Little Island campus, means there has never been a more exciting time to be part of the GBS story! Mirroring the existing Island House building, the new Island Hall facility extends our overall capacity to in excess of 1000 employees where Lilly will continue to offer a premium workspace across both buildings, complete with healthcare, pension and life assurance benefits, subsidised canteen, wellbeing facilities, barista, gym, travel subsidies, car-pooling incentives, bike to work scheme, on-site parking and much more.At the GBS, it’s not just about what we do today, but how we can continuously improve and innovate for present and future operations. We view the development of our highly skilled workforce in much the same way and want to grow your role into an empowering and fulfilling career here at Lilly. Therefore, with the sole purpose of employee progression, weekly Manager 1:1s, a dedicated Learning & Development service and Educational Assistance schemes all await you.Above all, it’s about being part of an open, welcoming and inclusive culture, one that is further enhanced by the dedication of our committees - Culture Club, Diversity & Inclusion, Sports & Social, Corporate Social Responsibility, Health Safety & Environment and Food.ResponsibilitiesThe 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 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.Project Management and Regional Operational KnowledgeUse project management skills, processes and tools to develop and execute local, regional and/or global clinical trials as described below:Scope - Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make changes (per change control process) as needed to meet the deliverables of the trial.Timeline – Develop and track global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies.Risk - Assess, identify and monitor trial-level risks. Incorporate scientific knowledge, trial process, and regional expertise to create one integrated trial-level risk mitigation and contingency plan.Budget - Understand the cross-functional, trial-level budget components. Create and monitor the overall budget and assumptions using financial tracking tools. Routinely network with appropriate business partners, on trial-level budget status and changes.Partner with other organizations to coordinate and actively participate in affiliate, site, and investigator trainingDrive and coordinate local, regional and global, cross-functional study team throughout study implementation, execution, and closure, empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution.Be accountable for trial/regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET).Manage relationships and serve as a single point of contact and central owner for trial communication to and from the Clinical Development, CDDA, and Third Party Organization (TPOs).Apply problem-solving skills to daily issues with cross-functional study team (including with vendors, affiliates/regions, global team members and other business partners).Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.Manage TPO qualification process, selection, and oversight.Clinical Trial Process Leadership and ExpertiseDemonstrate understanding of drug development process. Acknowledge inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise.Be knowledgeable of the global and regional operating model; coordinate and facilitate geographic and functional input to provide to the study teams.Accountable for ensuring a state of inspection readiness of the TMF records created, maintained, finalized, and owned by Clinical DevelopmentNetwork and leverage expertise to anticipate trial and regional issues, identify areas of process breakdown, assess situations and propose proactive approaches that reduce and/or mitigate risks that impact ability to deliver the clinical trial.Demonstrate ability to lead and influence in the midst of ambiguity and coach peers, cross-functional team members and TPOs on aspects of clinical trial process and regional specificities.Report, manage and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools from study implementation through closure.Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of clinical trials. Liaise with affiliates and other appropriate resources to understand local regulatory requirements.Scientific ExpertiseLeverage scientific and regulatory knowledge to prepare and/or provide 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, regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation.Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.Basic QualificationsBachelors or University degree (scientific or health-related field preferred) or an advanced degree.Additional Skills/PreferencesApplied knowledge of project management methodology, processes and toolsDemonstrated ability to work cross-culturally with global colleagues and with TPOsAbility to influence without authorityStrong leadership and networking skills exhibited while working in cross-functional and cross-cultural teams (internal & external) and on projectsEffective and influential communication, self-management, and organizational skillsDemonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguityFlexibility to adjust to altered prioritiesClinical trial experience with a strong working knowledge of the clinical research process.Proficiency in use of project management tools and techniques (e.g., Critical Chain, MS Project, MS, Excel, MS Powerpoint)Ability to travel periodicallyNote: 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.#WeAreLillyEli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.#WeAreLilly
