Clinical Trial Manager

BioBridges; United States; On-site; USD 130,000 - 145,000; Full time

Benefits offered by this job

Medical insurance

401(k)

Job summary

A leading company in the medical device sector is seeking a Clinical Trial Manager with neurovascular expertise. The role involves overseeing clinical trials, ensuring compliance with regulations, and managing vendor relationships. Candidates should have a strong background in clinical trial management and familiarity with FDA regulations. This is a contract position with opportunities for growth in a dynamic environment.

Qualifications

• Minimum of 5 years in clinical trial management within the medical device industry.
• Experience with neurovascular devices or interventional cardiology is highly desirable.

Responsibilities

• Lead the day-to-day execution of a U.S.-based neurovascular device trial.
• Develop and manage clinical trial protocols, timelines, and budgets.

Skills

Leadership

Data Management

Regulatory Compliance

Education

Bachelor’s degree in Life Sciences

Tools

Clinical Trial Management Systems

Electronic Data Capture

Job description

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Client Overview

BioBridges, a Career Portfolio Management company servicing the drug, device, and biologic development community, is supporting a client with a need for a Clinical Trial Manager (CTM) with neurovascular expertise.

Client Business Driver

Our client is a mid-size, private, global medical device company pioneering innovative neurovascular solutions to treat complex diseases such as stroke, aneurysms, and arteriovenous malformations.

The Work

The Clinical Trial Manager will lead the day-to-day execution of a U.S.-based neurovascular device trial, overseeing site management, vendor coordination, and compliance to ensure timely, high-quality results in support of regulatory goals.

Key Responsibilities

1. Study Planning & Execution: Develop and manage clinical trial protocols, timelines, and budgets.
2. Site Management: Oversee selection, training, and performance of clinical sites (hospitals, research centers).
3. Regulatory Compliance: Ensure all studies are conducted in accordance with FDA, EU MDR, ISO 14155, and Good Clinical Practice (GCP) guidelines.
4. Vendor Oversight: Manage CROs (Clinical Research Organizations), labs, and other vendors supporting the trial.
5. Data Management: Collaborate on case report forms (CRFs), database setup, and timely data cleaning and review.
6. Cross-Functional Collaboration: Work closely with R&D, regulatory, quality, and marketing teams to align trial outcomes with product development and commercialization.
7. Monitoring & Reporting: Track trial metrics, manage risk, and report on trial progress to internal stakeholders and regulatory bodies.

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related field.
• Minimum of 5 years in clinical trial management within the medical device industry.
• Proven track record in managing end-to-end clinical trial processes, including study design, site selection, monitoring, and close-out.
• Experience with neurovascular devices or interventional cardiology is highly desirable.
• In-depth understanding of FDA regulations, ICH-GCP guidelines, and ISO standards pertinent to clinical trials.
• Familiarity with regulatory submissions (e.g., IDE, PMA) and interactions with regulatory bodies.
• Proficiency in Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) tools.
• Ability to analyze and interpret clinical data, ensuring data integrity and compliance.
• Strong leadership and team management capabilities.

Preferred Skills

• Advanced degree in Life Sciences

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Health Care Provider and Research

Industries

• Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research

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Inferred from the description for this job

Medical insurance

401(k)

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