Associate/Sr. Associate/Manager, Clinical Development Trial Lead (CDTL)

Eli Lilly • Stamford, CT

290d • $69,000 - $154,000

About The Position

The Clinical Development Trial Lead (CDTL) Associate/Sr. Associate/Manager 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 uses 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.

Requirements

• 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

Nice To Haves

• 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
• 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

Responsibilities

• 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.
• Develop and track global milestones by gaining alignment and integrating inputs across functions and geographies.
• Assess, identify and monitor trial-level risks.
• Create and monitor the grants and non-grants, and assumptions using tracking tools.
• 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 starting from country allocation through Last Patient Entered Treatment.
• Handle relationships and serve as a single point of contact and central owner for trial communication.
• Apply problem-solving skills to daily issues with cross-functional study team.
• Identify and assist in developing continuous improvement activities based on meaningful trends.
• Handle TPO qualification process, selection, and oversight.
• Demonstrate understanding of drug development process.
• Single point of accountability for the Trial Master File.
• Network and apply expertise to anticipate trial and regional issues.
• Coach peers, cross-functional team members and TPOs on aspects of clinical trial process.
• Use scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents.

Benefits

• Eligibility to participate in a 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree