Sr. Clinical Trial Manager

Stratacuity: Proven Scientific Placement; Burlington (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Stratacuity: Proven Scientific Placement seeks an experienced Senior Clinical Trial Manager to lead Phase II/III trial execution across multiple programs, ensuring timelines, quality, regulatory compliance, and budget adherence. The role oversees startup through closeout as the operational lead for assigned trials.

The Sr. CTM will coordinate cross-functional teams across Clinical Development, Medical Monitoring, Data Management, Biostatistics, Regulatory Affairs, and Quality to drive timelines

Qualifications

• 8+ years of clinical research experience.
• 3+ years in a Clinical Trial Manager or leadership role.
• Experience managing Phase II and/or Phase III studies in biotech or pharma.

Responsibilities

• Lead day-to-day management of Phase II/III trials from startup to closeout.
• Develop and maintain study timelines, enrollment forecasts, risk plans, and metrics.
• Drive CRO/vendor oversight and delivery against milestones.
• Partner with Clinical Development, Medical Monitoring, Data Management, Biostatistics, Regulatory Affairs, Pharmacovigilance, Clinical Supply and Quality.
• Support site selection, activation, enrollment, retention, and closeout activities.

Skills

Leadership

CRO management

Regulatory compliance

Project management

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field

Job description

Our Burlington based, rapidly growing clinical-stage biotechnology client is seeking an experienced Senior Clinical Trial Manager (Sr. CTM) to lead the operational execution of Phase II and Phase III clinical studies across multiple development programs. This individual will serve as the operational lead for assigned trials, overseeing study conduct from startup through closeout while ensuring timelines, quality, regulatory compliance, and budget objectives are met.

Key Responsibilities:

• Lead the day-to-day management of Phase II/III clinical trials from startup through database lock and study closeout.
• Develop and maintain study timelines, enrollment forecasts, risk management plans, and operational metrics.
• Drive CRO and vendor oversight, performance management, and delivery against study milestones.
• Partner cross-functionally with Clinical Development, Medical Monitoring, Data Management, Biostatistics, Regulatory Affairs, Pharmacovigilance, Clinical Supply, and Quality teams.
• Support site selection, activation, enrollment, retention, and closeout activities.
• Monitor study progress, data quality, protocol compliance, and key performance indicators.
• Ensure adherence to ICH-GCP, FDA regulations, company SOPs, and global clinical trial standards.
• Contribute to study budgets, forecasting, vendor payments, and financial tracking.

Qualifications:

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field.
• 8+ years of clinical research experience, including 3+ years in a Clinical Trial Manager or comparable leadership role.
• Experience managing Phase II and/or Phase III studies within biotech or pharmaceutical environments.
• Strong CRO and vendor management experience.
• Deep understanding of ICH-GCP, FDA regulations, and global clinical operations.
• Demonstrated ability to lead cross-functional teams and manage multiple priorities in a fast-paced environment.

Preferred Experience:

• Advanced degree (MS, MPH, PharmD, or equivalent).
• Therapeutic area experience in rare disease, endocrinology, metabolic disease, or related fields.
• Experience supporting NDA/BLA-enabling studies.
• Background working in a high-growth biotechnology company.