Job Title:
Clinical Development Trial Lead (CDTL)
Location:
Bangalore, Karnataka, India
Job Type:
Full-Time | Regular
Job ID: R-84583
Department: Research & Development
Position Summary:
The Clinical Development Trial Lead (CDTL) leads cross-functional study teams to plan, execute, and close clinical trials aligned with exploratory and biopharmaceutics clinical development strategies. This role is responsible for delivering high-quality, on-time, and within-budget studies while ensuring compliance with regulatory and corporate standards.
Key Responsibilities:
Project Management & Execution
Define study scope, manage timelines, monitor enrollment progress, and oversee risk and budget.
Lead cross-functional teams and act as primary contact for all trial-related communications.
Coordinate local, regional, and global implementation with strong issue resolution and contingency planning.
Clinical Trial Process Leadership
Ensure trial inspection readiness, TMF quality, and adherence to GCP and regulatory guidelines.
Oversee vendor (TPO) qualification, selection, and performance.
Lead trial-level decision-making and continuous process improvement initiatives.
Scientific & Regulatory Support
Apply clinical and regulatory expertise to support trial design, feasibility assessments, and regulatory responses.
Influence trial outcomes by integrating scientific and operational insights.
Basic Qualifications:
Bachelor's degree in a scientific or health-related field (or equivalent)
Minimum 10 years of clinical research or scientific experience
Experience in clinical trial operations, monitoring, or affiliate-level roles
Preferred Qualifications:
Advanced degree (MSc/PharmD/PhD)
Strong leadership, collaboration, and communication skills
Experience in regulatory documentation and inspection-readiness processes
Familiarity with project management tools
Willingness to travel (up to 10%)
Core Competencies:
Cross-functional leadership
Strategic problem solving
Risk and quality management
Clinical trial lifecycle management
Stakeholder and vendor management
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