Senior Clinical Trial Manager

Sr. Clinical Trial Manager

The Senior Clinical Trial Manager provides strategic leadership and hands-on oversight for complex, global, and high-priority clinical trials. This role is accountable for end-to-end study execution, including vendor and CRO oversight, budget and timeline management, quality and compliance, and proactive risk mitigation.

The Senior Clinical Trial Manager serves as the Clinical Operations lead on cross-functional teams, driving operational excellence across study start-up, site activation, monitoring, and enrollment for a global Phase III trial in the rare disease and neuromuscular space.

Responsibilities

• Provide sponsor oversight of CROs and all outsourced study activities, ensuring high-quality execution and adherence to contractual obligations.
• Lead and manage global Phase III clinical trials, including complex and multi-country studies with numerous vendors and sites.
• Own study timelines, milestones, and deliverables, and manage budgets, forecasts, and accruals to ensure projects remain on track and within financial expectations.
• Drive site feasibility activities to identify and select appropriate study sites across multiple countries.
• Lead global study start-up activities, including submissions, approvals, site activation, and initiation, with a focus on rapid and efficient execution.
• Oversee and support enrollment strategy and execution, including monitoring enrollment progress to achieve targeted recruitment of approximately 90 patients by the planned last patient date in 2028.
• Monitor and oversee CRO performance, including project-level activities, to ensure alignment with study goals and timelines.
• Review and interpret data quality metrics, enrollment reports, protocol deviations, monitoring reports, and study readiness assessments, and take corrective actions as needed.
• Ensure compliance with ICH/GCP standards, internal SOPs, and applicable regulatory requirements across all study activities.
• Lead the implementation, validation, and ongoing oversight of study systems and databases, including CTMS and related tools.
• Collaborate closely with cross-functional teams, including Clinical Operations, Development, vendors, investigators, and study sites, to resolve issues and maintain operational momentum.
• Proactively identify operational risks and develop mitigation strategies to keep the study on time and within scope.
• Support and guide site monitoring and query resolution activities to maintain clean, high-quality data.
• Contribute to continuous improvement of clinical operations processes and tools by sharing best practices and lessons learned.
• Hit the ground running operationally by quickly understanding the study design, operational plan, and vendor landscape for a global Phase III trial in a rare disease and neuromuscular indication.

Essential Skills

• Bachelor's degree required.
• Minimum of 5 years of clinical trial management experience in biotechnology or pharmaceutical settings.
• Demonstrated independent leadership of global or complex clinical studies.
• Proven experience managing CROs and external vendors at a project management or equivalent level.
• Hands-on experience with study start-up, including submissions, site activation, monitoring, and enrollment management, within the last 2 years.
• Experience managing study budgets, financial forecasts, timelines, and overall study execution.
• Experience in rare disease and/or neuromuscular clinical research is preferred.

Work Environment

• The role is based in a fast-paced, cross-functional biotechnology environment that emphasizes collaboration, operational excellence, quality, compliance, and execution.
• The office is particularly active Monday through Thursday, creating frequent opportunities to collaborate in person and build strong cross-functional relationships.
• Flexible start times, typically between 7:30 a.m. and 9:00 a.m., support work-life balance while maintaining a strong on-site presence.
• The role offers significant exposure to leadership and executives, providing visibility and influence within the organization.

Job Type & Location

This is a Contract position based out of Waltham, MA.

Pay and Benefits

The pay range for this position is $88.00 - $103.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Waltham, MA.

Final date to receive applications

This position is anticipated to close on Jul 31, 2026.

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