Senior Clinical Project Manager: Lead Global Trials

Biorasi; Miami (FL); On-site; USD 95,000 - 140,000; Full time

Benefits offered by this job

Half-day Fridays

Vacation & Sick Time

401K Matching

Tuition Reimbursement

Career Growth & Training

Job summary

Biorasi is seeking a Senior Project Manager to lead complex, global clinical trials. You will drive the full lifecycle from startup to close-out, coordinate cross-functional teams, ensure TMF integrity, and manage timelines and budgets to meet sponsor expectations.

You will mentor teams, coordinate with vendors, prepare trainings and meetings, and ensure adherence to ICH GCP and regulatory requirements. Strong leadership and communication are essential.

Qualifications

• Bachelor’s Degree or higher in a scientific discipline preferred.
• Fluent English (oral and written).
• 8+ years experience with Project Management responsibilities, preferably in the clinical research industry.
• 5+ years supervising and managing large cross-functional teams.
• Strong problem solving, management and leadership skills.
• Excellent verbal, written communication, and presentation skills.
• Good knowledge of Project Management processes and understanding of ICH GCP and regulatory requirements.

Responsibilities

• Oversee the complete project lifecycle from planning and start up to execution and close out in alignment with the project work breakdown structure.
• Provide leadership to internal and cross functional teams across various geographic locations by distributing tasks, tracking performance, resolving issues, and managing change to optimize project performance.
• May lead trainings and meetings, ensure documentation pre/post meetings are completed, distributed, and filed accordingly.
• May lead vendor qualification and selection and oversee vendor performance and delivery.
• Oversee TMF creation, maintenance, and quality from initiation to archival.
• Monitor and report on project health across financials, timelines, resources, issues and risks, and initiate change orders when needed.
• Oversee site documentation, regulatory approvals, and IP release processes.
• May manage site recruitment strategies and campaigns and communications across sites.
• Coordinate with clinical team to plan monitoring visits and review trip reports.
• Perform periodic review of documentation and study conduct to ensure SOP compliance.
• Attend trainings and meetings to develop knowledge, techniques and skills.
• Support project acquisition activities, including proposal development, presentations, bid grids, site and vendor feasibility and cost estimation.

Skills

Fluent English

Leadership

Communication skills

Presentation skills

Problem solving

Education

Bachelor’s degree or higher in a scientific discipline

Job description

Biorasi is seeking a Senior Project Manager to lead complex, global clinical trials. You will drive the full lifecycle from startup to close-out, coordinate cross-functional teams, ensure TMF integrity, and manage timelines and budgets to meet sponsor expectations.

You will mentor teams, coordinate with vendors, prepare trainings and meetings, and ensure adherence to ICH GCP and regulatory requirements. Strong leadership and communication are essential.