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Senior Associate / Manager - Clinical Development Trial Lead, Cork City
Client: Lilly
Location: Cork City, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: cf453a0c9bfb
Job Views: 106
Posted: 03.03.2025
Expiry Date: 17.04.2025
Job Description:
We’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, 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 41,000 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.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. In-house People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
Purpose:
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.
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.
* Trial Leadership, and Regional Operational Knowledge - Use 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.
* Timeline – Develop and track global milestones by gaining alignment and integrating inputs across functions and geographies.
* Risk - Assess, identify and monitor trial-level risks.
* Budget - Understand the cross-functional, trial-level budget components.
* Partner with other organizations to coordinate and deliver Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs).
* Drive and coordinate local, regional and global, cross-functional study team throughout study implementation, execution and closure.
* Be accountable for trial/regional enrollment strategy and execution.
* Manage relationships and serve as a single point of contact for trial communication.
* Apply problem-solving skills to daily issues with cross-functional study team.
* Identify and assist in developing continuous improvement activities.
* Manage TPO qualification process, selection, and oversight.
* Clinical Trial Process Leadership and Expertise - Demonstrate understanding of drug development process.
* Look for opportunities to expand and deepen clinical trial process expertise.
* Single point of accountability for the Trial Master File.
* Network and leverage expertise to anticipate trial and regional issues.
* Demonstrate ability to lead and influence in the midst of ambiguity.
* Coach peers and cross-functional team members on clinical trial process.
* Apply expertise and knowledge of global/regional regulations.
* Scientific Expertise - Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents.
* Combine scientific clinical trial operational knowledge, and process expertise to impact clinical trial design.
* Utilize clinical development knowledge, problem solving and critical thinking skills.
* 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.
* Ability to influence without authority.
* Strong leadership and networking skills.
* Effective and influential communication, self-management, and organizational skills.
* Demonstrated ability to manage complex situations through problem-solving.
* Flexibility to adjust to altered priorities.
Other Information/Additional Preferences:
* Need to travel periodically to AST/ ISST/Investigator Engagement meetings.
* Note: When applying internally for a position your current supervisor receives notification that you have applied to the position.
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