Associate/Sr Associate - Clinical Development Trial Lead (CDTL)
Eli Lilly
- Cork
- Permanent
- Full-time
- Use processes and tools to develop, execute, and deliver local, regional and/or global clinical trials as described below:
- 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 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) o 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.
- 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.
- 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
- 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.
- 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 priorities