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Senior Associate / Manager - Clinical Development Trial Lead, Cork
Client: Lilly
Location: Cork, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: cf453a0c9bfb
Job Views: 81
Posted: 21.01.2025
Expiry Date: 07.03.2025
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. We’re looking for people who are determined to make life better for patients around the world.
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. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
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. 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.
* Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make changes as needed.
* Develop and track global milestones by gaining alignment and integrating inputs across functions and geographies.
* Assess, identify and monitor trial-level risks and incorporate scientific knowledge to create a risk mitigation plan.
* Understand the cross-functional trial-level budget components and monitor status and changes.
* Drive and coordinate cross-functional study team throughout study implementation.
* 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 the study team.
* Identify and assist in developing continuous improvement activities.
Clinical Trial Process Leadership and Expertise:
* Demonstrate understanding of drug development process and inter-relatedness of cross-functional activities.
* Look for opportunities to expand 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 aspects of clinical trial process.
Scientific Expertise:
* Leverage scientific and regulatory knowledge to prepare clinical and regulatory documents.
* Utilize clinical development knowledge and problem-solving skills to support clinical programs.
* Bachelors or University degree (scientific or health-related field preferred) and 3 years clinical research experience or relevant clinical trial experience; or an advanced degree.
Highly Desired Skills:
* Applied knowledge of trial execution methodology and processes.
* Demonstrated ability to work cross-culturally with global colleagues.
* Ability to influence without authority.
* Strong leadership and networking skills.
* Effective and influential communication skills.
* Flexibility to adjust to altered priorities.
Other Information/Additional Preferences:
* Need to travel periodically to meetings.
* Note: When applying internally for a position your current supervisor receives notification that you have applied to the position.
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