Senior Clinical Trial Manager (Boston, MA; Dallas, TX; ...)

Job Overview:
We are seeking a highly experienced Senior Clinical Trial Manager on a contract basis to lead and oversee the successful execution of clinical trials. In this role, you will be responsible for managing all aspects of the trial process, from startup through closeout, ensuring that studies are conducted on time, within budget, and in compliance with regulatory standards.

This position is open to candidates in various locations.
 

Key Responsibilities:

Clinical Trial Oversight & Leadership

• Lead the planning, execution, and completion of clinical trials across all phases, ensuring adherence to timelines, budgets, and study protocols.
• Serve as the primary point of contact for internal teams, external vendors, and study sites throughout the clinical trial process.
• Develop, manage, and oversee study plans, timelines, and project milestones to ensure smooth trial operations.

Regulatory & Compliance Management

• Ensure all clinical trial activities are conducted in accordance with GCP, FDA, EMA, and other applicable regulatory standards.
• Oversee the preparation and review of essential regulatory documents, including informed consent forms, study protocols, and clinical reports.

Team Management & Collaboration

• Manage and mentor study teams, providing guidance, support, and ensuring project goals are met.
• Coordinate cross-functional activities, collaborating closely with data management, biostatistics, regulatory affairs, and clinical operations teams.
• Identify potential study challenges and proactively develop and implement solutions to keep trials on track.

Vendor & Budget Management

• Oversee external vendors, such as CROs and laboratories, ensuring adherence to contracts and study requirements.
• Monitor and manage trial budgets, ensuring cost-effective operations while maintaining high standards of quality and compliance.
• Approve and track trial expenditures to ensure alignment with budget guidelines.

Data Review & Reporting

• Monitor study progress, reviewing clinical data for accuracy and completeness, and address any issues that arise during the trial.
• Contribute to the preparation of study reports, presentations, and documentation for regulatory submissions and internal review.

Qualifications:

• Bachelor’s degree in life sciences, healthcare, or a related field; an advanced degree is preferred.
• 5+ years of experience managing clinical trials, with a strong understanding of clinical operations and regulatory requirements.
• Proven experience leading cross-functional teams and managing multiple clinical studies.
• Strong knowledge of GCP, FDA, EMA regulations, and overall clinical trial management best practices.
• Excellent communication, organizational, and problem-solving skills.

This is a contract position