Eli Lilly and Company · 9 hours ago
Associate/Sr. Associate/Manager, Clinical Development Trial Lead (CDTL)
Stamford, CT
Full-time
Onsite
Entry, Mid Level
$69K/yr - $154K/yr
3+ years expEli Lilly and Company is a global healthcare leader dedicated to making life better for people around the world. They are seeking a Clinical Development Trial Lead (CDTL) Associate/Sr. Associate/Manager to lead cross-functional study teams in the development and execution of clinical trials, ensuring quality, timeliness, and adherence to budget constraints.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Use processes and tools to develop, execute, and deliver local, regional and/or global clinical trials as described below:
Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make changes as needed to meet the deliverables of the trial
Develop and track global milestones by gaining alignment and integrating inputs across functions and geographies
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
Understand the cross-functional, trial-level budget components. Create and monitor the grants and non-grants, and assumptions using tracking tools. Routinely network with business partners on trial-level budget status and changes
Partner with organizations to coordinate and deliver training and 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
Partner with the Investigator Engagement organization to achieve regional enrollment goals
Handle 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 meaningful trends such as industry, regulatory, new technology, etc
Handle 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 acquiring 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 apply 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
Use 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
Use clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business and clinical programs
Qualification
Required
Bachelor's degree (scientific or health-related field preferred)
3+ years clinical research experience or relevant clinical trial experience in a scientific or health-related field
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
Preferred
Experience with early phase oncology
Experience with Radioligand Therapy (RLT)
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 handle complex situations through problem-solving, critical thinking and navigating ambiguity
Flexibility to adjust to altered priorities
Need to travel periodically to Investigator Engagement meetings and other scientific or regional symposiums
Benefits
Company-sponsored 401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-02-06
2026-02-06
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