Associate / Senior Associate - Clinical Trial Project Management, Exploratory Medicine
Apply locations
Ireland, Cork
Time type
Full time
Posted on
Posted 2 Days Ago
Job requisition id
R-70529
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 work to discover and bring life-changing medicines to those in need, improve understanding and management of disease, and give back through philanthropy and volunteerism. We prioritize putting people first and strive to make a positive impact.
Eli Lilly Cork comprises over 2000 employees from 60 nationalities, delivering innovative solutions across various Business Service functions including Finance, IT, Medical, and Clinical Trials. The Cork campus offers a premium workspace with flexible hybrid options, healthcare, pension, life assurance, subsidized canteen, onsite gym, travel subsidies, and parking. We also provide in-house development services, educational assistance, and wellbeing initiatives to enhance your career experience.
We are committed to diversity, equity, and inclusion (DEI), ensuring representation across ethnicities, nationalities, cultures, generations, sexualities, disabilities, and gender identities through our four pillars: EnAble, embRACE, LGBTQ+ & Ally, and GIN-Gender Inclusion Network. EnAble focuses on accessibility and disability confidence.
Join us to be creative, innovative, and authentic
Overview:
The Clinical Trial Project Manager (CTPM) Associate leads cross-functional study teams in developing and executing clinical trials, accountable for delivering trials with quality, on time, and within scope and budget. They leverage project management, regional operational knowledge, and scientific expertise to drive actions and coordinate efforts to meet or exceed deliverables.
Primary Responsibilities:
This description provides a general overview of the job requirements. Responsibilities may evolve over time and include additional duties. Consult with your supervisor for your specific responsibilities.
Project Management and Regional Operational Knowledge
- Utilize project management tools and processes to develop and execute clinical trials, including scope, timeline, risk assessment, and budget management.
- Coordinate Investigator Study Specific Training (ISSTs) and Affiliate Study Training (ASTs).
- Drive and coordinate study teams through implementation and closure, ensuring trial deliverables are met, issues are managed, and risks mitigated.
- Manage trial/regional enrollment strategies and execution, partnering with regional operations.
- Serve as a communication point for trial-related information among stakeholders.
- Apply problem-solving skills to daily issues and identify continuous improvement activities.
- Manage TPO qualification, selection, and oversight.
Clinical Trial Process Leadership and Expertise
- Understand drug development processes and cross-functional activities, aiming to deepen clinical trial process expertise.
- Coordinate with regional teams, ensure trial master file readiness, and anticipate issues to mitigate risks.
- Lead and influence in ambiguous situations, coaching peers and team members.
- Ensure accurate and complete documentation across systems from start to finish.
- Apply knowledge of regulations, GCP, and Lilly standards, liaising with affiliates to understand local requirements.
Scientific Expertise
- Leverage scientific and regulatory knowledge for document preparation, meetings, and responses.
- Impact trial design and feasibility through combined scientific, operational, and process knowledge.
- Use critical thinking to support scientific needs of the business.
Minimum Qualification Requirements:
- Bachelor's degree in a scientific or health-related field, with 3 years of clinical research or relevant experience; or an advanced degree.
Highly Desired Skills:
- Knowledge of project management methodologies, cross-cultural collaboration, influencing skills, leadership, communication, problem-solving, flexibility, and clinical trial experience.
Additional preferences include experience in exploratory and biopharmaceutics development, trial site or affiliate experience, proficiency with project management tools, and ability to travel up to 10%.
Note: Internal applicants are encouraged to discuss with their supervisor before applying. Lilly promotes workplace accessibility and nondiscrimination. For accommodations, complete the request form at this link.
Similar Jobs (3)
- Sr Associate / Manager - Clinical Development Trial Lead
- Associate / Senior Associate - Clinical Trial Packaging Material Coordinator - Finished Goods (FING)
- Sr. Associate/ Principal Associate - Clinical Trial Quality Representative (MQO)
At Lilly, we care about our employees and our shared purpose of improving lives worldwide. Join us to be part of a team that values inclusion, innovation, and excellence.
#J-18808-Ljbffr