Clinical Trial Study Manager

Summarized Purpose: The Senior Clinical Trial Manager (Sr. CTM) or Project Lead, with global experience, is responsible for achieving clinical deliverables within the specified contract period. This includes making informed business decisions with line management support, ensuring clinical deliverables meet customer expectations, and managing clinical activity within contract scope to maintain profitability.

Essential Functions:

• Manage all clinical operational and quality aspects of allocated studies (moderate to high complexity) in compliance with ICH GCP.
• Develop clinical tools (e.g., Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan.
• Ensure timely setup, organization, and quality of the Trial Master File.
• Collaborate with the project manager and clinical team to meet project deliverables.
• Implement and train standardized clinical monitoring processes.
• Monitor clinical trials, manage timelines, and ensure contractual obligations are met.
• Communicate with study sites regarding protocol and study-related issues.
• Coordinate start-up activities and ensure timely regulatory submissions.
• Provide input into preparation of forecast estimates for clinical activities.
• Manage clinical resources, assignments, and additional resource requirements.

Education and Experience:

• Bachelor's degree or equivalent in a relevant field.
• 8+ years of relevant experience.
• Combination of education, training, and/or directly related experience may suffice.

Knowledge, Skills, and Abilities:

• Strong leadership, planning, and organizational skills.
• Effective mentoring, training, and team motivation abilities.
• Comprehensive understanding of clinical monitoring practices and regulations (ICH/GCP, FDA).
• Strong judgment, decision-making, and problem-solving skills.
• Effective oral and written communication skills.
• Financial acumen and budgeting/forecasting knowledge.
• Ability to manage clinical-only studies independently.

Comments for Suppliers: Candidates must have 5+ years in the pharmaceutical industry or clinical research organization, 3+ years as a clinical study manager (global oversight), and extensive global study experience. Responsibilities include vendor management, inspection readiness, and study management activities.