Senior Clinical Project Manager

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

We are Growing! Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization.

Biorasi is looking for top performers who are as passionate about clinical research as we are – clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.

Your role:

• 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 or direct the activities for preparation and delivery of key trainings and meetings over the course of a project, ensure all relevant documentation pre/post meetings are completed, distributed, and filed accordingly.
• May lead or direct the vendor qualification and selection as well as the performance and delivery of services by vendors throughout the course of the project.
• Oversee the timely creation, maintenance, and quality check of the Trial Master File (TMF) starting from the initiation of the project until the final delivery to the Sponsor or archival of the TMF.
• Monitor, control, analyze and report on project’s health from financial, timeline, resources, issues and risks perspective; identify and communicate any changes and initiate change orders when necessary.
• Oversee the development, collection and tracking of site documentation, regulatory approvals, and IP release process.
• May manage site recruitment strategies and campaigns and the communication across sites as needed throughout a clinical trial.
• May support clinical activities by coordinating with clinical team to plan monitoring visits and perform trip reports reviews.
• Perform periodic review of documentation generation and study conduct to ensure compliance with plans and SOPs.
• Attend any branch and role specific trainings and meetings to develop and enhance relevant knowledge, techniques, and skills.
• Support project acquisition activities, including but not limited to, proposal development, presentation development, bid grid formulation, site and vendor feasibility and cost estimation.

Your Profile:

• Bachelor’s Degree or higher in a scientific discipline preferred.
• Fluent English (oral and written).
• 8 years or more experience with Project Management responsibilities, preferably in the clinical research industry.
• 5 years or more experience in 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 applicable regulatory requirements

We strive to provide our employees and their families with benefits that are thoughtfully designed to enhance your health and well-being. Our employees enjoy half-day Fridays, paid time off to include vacation, holidays, and sick days, medical, dental, vision, life insurance, short-term and long-term disability, company matching 401K, employee bonus programs, tuition reimbursement, career growth, training and development.