Job Title:
Clinical Development Trial Lead (CDTL)
Location:
Bangalore, Karnataka, India
Company:
Lilly
Job Description:
The Clinical Development Trial Lead (CDTL) will be responsible for leading the planning and execution of exploratory and biopharmaceutics clinical development studies/trials. The CDTL ensures the successful on-time, on-budget fulfillment of study deliverables, with a strong emphasis on risk management, cross-functional coordination, and continuous process improvement. This role involves managing study teams, trial-level risks, timelines, budgets, and regulatory requirements.
Key Responsibilities:
Project Management:
Monitor and adjust scope, timeline, and budget to ensure the successful execution of clinical studies/trials.
Develop and track the enrollment plan, coordinating with multiple functions and geographies.
Assess and mitigate trial-level risks, ensuring integrated risk plans are in place.
Act as a central point of communication for trial-related queries.
Clinical Trial Leadership:
Lead cross-functional teams in the execution of clinical studies, from planning through closure.
Ensure trial records and documents are inspection-ready and maintain compliance with GCP.
Identify continuous improvement opportunities based on trends in industry, regulatory, and technological advancements.
Scientific and Regulatory Expertise:
Provide technical consultation and leverage scientific knowledge to impact trial design and implementation.
Ensure alignment with global/regional regulations and Lilly’s operating standards.
Required Qualifications:
Education:
Bachelor’s or University degree (scientific or health-related field preferred).
10 years of clinical research experience or relevant experience in a scientific or health-related field; or an advanced degree.
Skills and Experience:
Strong leadership and networking skills.
Excellent communication, problem-solving, and organizational abilities.
Ability to work in cross-functional teams.
Proficiency with project management tools.
Ability to travel up to 10% of the time.
Preferred Skills:
Clinical trial site-level or affiliate experience.
Strong attention to detail, critical thinking, and analytical abilities.
Benefits:
Opportunities for career development and growth.
Competitive salary and benefits package.
Collaborative work environment.
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