Job Title: Clinical Research Study Management & Protocol Amendment Specialist

Summary:

Seeking a skilled professional to manage clinical trial protocol amendments from intake through implementation, clear existing backlogs, and coordinate amendments across multiple departments. This role requires expertise in clinical research operations, study startup and maintenance, and understanding the financial and operational impacts of protocol changes. The position supports the implementation of a centralized study management process and requires strong cross-functional coordination skills.

Responsibilities:

• Oversee the full lifecycle of clinical trial protocol amendments, including intake, assessment, prioritization, tracking, and follow-up to ensure timely completion.
• Coordinate amendment activities across Regulatory, Contracts, Budgets, Finance, CTMS, and site operations, serving as a central point of contact for all stakeholders.
• Evaluate and communicate the operational and financial impacts of protocol amendments, ensuring necessary updates to budgets, contracts, and CTMS records.
• Identify and escalate amendments that are aged, impact patient enrollment, or have significant operational or financial consequences.
• Support the implementation and ongoing improvement of a centralized study management intake and oversight process.
• Maintain accurate documentation, tracking data, and provide regular updates on amendment status, backlog volume, and turnaround times.
• Identify process bottlenecks and recommend workflow improvements to enhance amendment turnaround and study maintenance efficiency.
• Ensure consistent cross-functional communication, accountability, and timely follow-up to align protocol changes with operational requirements.

Qualifications:

• Experience in clinical research study startup, study maintenance, or clinical trial operations.
• Direct, hands-on experience managing protocol amendments through the entire amendment lifecycle.
• Strong understanding of the impact of protocol modifications on regulatory submissions, study operations, budgets, contracts, and CTMS.
• Proven ability to coordinate across multiple clinical research functional teams.
• Ability to independently prioritize and manage a high volume of amendments and competing deadlines.
• Excellent organizational, project management, communication, and problem-solving skills.
• Oncology therapeutic area experience preferred.

Published Category: Clinical Operations & Development