Senior Associate / Manager - Clinical Development Trial Lead
Eli Lilly
- Cork
- Permanent
- Full-time
The 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.Trial Leadership, and Regional Operational Knowledge -Use processes and tools to develop, execute, and deliver 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 milestones 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 grants and non-grants, 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 deliver Investigator Study Specific Training (ISSTs)/ Affiliate StudyTraining (ASTs)/Investigator Engagement Meetings.
Drive 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)
Partner with the Investigator Engagement organization to achieve regional enrollment goals.
Manage relationships and serve as a single point of contact and central owner for trial communication, to and from the Clinical Design and Delivery organization, all cross functional team members, 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 Expertise -
Demonstrate 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 obtaining regional input to provide to the study teams.Single point of accountability for the Trial Master File, working closely with functional record owners to ensure the file is current and inspection ready at all times.
Network 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.
Coach peers, cross-functional team members and TPOs on aspects of clinical trial process and regional specificities.
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 Expertise -
Leverage 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 clinical trial operational knowledge, and process expertise to impact clinical trial design, feasibility implementation, and execution.
Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business and clinical programs.Minimum Qualification Requirements:
Bachelors 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 Skills:
Applied knowledge of trial execution methodology, processes, and tools
Demonstrated ability to work cross-culturally with global colleagues and with TPOs
Ability to influence without authority
Strong leadership and networking skills exhibited while working in cross-functional and cross-cultural teams (internal & external) and on projects
Effective and influential communication, self-management, and organizational skills
Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguity
Flexibility to adjust to altered prioritiesOther Information/Additional Preferences:
Need to travel periodically to AST/ ISST/Investigator Engagement meetings and potentially other scientific or regional symposiumsEli 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