Senior Clinical Trial Manager

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Oversee the daily operations of clinical trials in collaboration with internal cross-functional study teams and CRO team members.

• Organize internal team meetings and deliver updates on study status.

• Act as the primary liaison for the CRO regarding study startup, monitoring, site management, and close-out activities.

• Anticipate project requirements and take decisive actions accordingly.

• Monitor, track, and report on site and study performance metrics, budgets, and timelines.

• Address issues with Clinical Operations and implement corrective measures.

• Review monitoring trip reports and provide constructive feedback to the CRO.

• Ensure adherence to GCP, ICH, and regulatory standards.

• Serve as the main contact for select clinical trial vendors, ensuring timely and high-quality deliverables.

• Provide regular updates and reports to stakeholders.

• Review TMF files to ensure completeness and readiness for inspection.

• Ensure study operations align with established study plans.

• Collaborate with internal study teams and CROs to prioritize data integrity and participant safety.

• Monitor quality issues and implement prompt quality-control measures.

• Assist with reviews, assessments, and analysis of study-level budgets.

• Perform additional duties as assigned.

⛳️ Requirements

• Excellent and clear communication skills with investigators and site study-team members.

• Strong organizational skills and attention to follow-through.

• Ability to prioritize and adapt independently in a constantly evolving clinical trial landscape.

• Independent thinking and the ability to act swiftly in a fast-paced environment.

• A proactive approach to assignments and responsibilities.

• Willingness to ask questions and seek answers as part of an ongoing learning process.

• Capacity to hold team members and oneself accountable for critical deliverables.

• Proven experience in managing CRO relationships, trial timelines, and study budgets within a sponsor or CRO context.

• Proficiency in clinical trial management systems and Microsoft Office applications.

• Bachelor's degree in life sciences, health sciences, or a related field.

• At least 12 years of experience in clinical research.

• Demonstrated experience in managing multicenter/multinational late-stage clinical trials.

• Working knowledge of GCP, FDA regulations including 21 CFR Part 312, and ICH guidelines.

• Professional certification such as CCRP, CCRA, or PMP is preferred.

• Prior experience in clinical-stage biotech or startup settings is advantageous.

• Familiarity with hospital-based clinical trials is beneficial.

• Experience with international/multinational trials is a plus.

• Experience using Smartsheet is desirable.

🏝️ Benefits

• Equal opportunity employer.

• Travel may be required (20-30%), depending on the program stage.