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Clinical Development Trial Lead

10+ years
Not Disclosed
10 June 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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