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Clinical Trials Lead (Lead Clinical Research Associate)

Avania

Full-time
5-10 years experience
On-site

Key Skills

Clinical Research
Medical Device Monitoring
MedTech
Team Supervision
Clinical Trial Management
Project Coordination
Peer Review
Monitoring Tools Development
Study Documentation
Corrective Actions
Clinical Standards
Regulatory Compliance

Job Description

Avania is hiring - Clinical Trials Lead (Lead Clinical Research Associate!)

As Clinical Trials Lead (Lead Clinical Research Associate), you will work with a sponsoring company in the monitoring of medical device and MedTech studies with an emphasis placed on ensuring the highest ethical and clinical standards.

You will also assume a key role in the monitoring team by supervising project-specific monitoring activities, coordinating project-specific training, and interacting with our clients. Avania's Lead Clinical Research Associate (CTL / Lead CRA) acts as the primary contact for study questions from the monitoring team, organizes team training and study updates, and generates necessary monitoring tools. You will ensure monitoring visits are being conducted as needed and tasks are being completed in an appropriate and timely manner. Further, you will complete peer review of required study documentation to ensure these are accurate, complete, and of high quality. You will also represent Avania on study conference calls and/or meetings.

The Lead CRA will collaborate with the Project Manager to ensure study objectives are met. You may also handle CRA study activities as needed. Finally, you will provide CRA support, including such activities as assisting Clinical Research Associates with difficult or challenging situations or corrective actions, conducting co-visits and providing feedback, reviewing monitoring reports, and similar work.

This position requires travel approximately 25 – 30% of the time.

Core Responsibilities

The Clinical Trials Lead supervises monitoring activities, coordinates team training, and acts as the primary contact for study-related questions. They also perform peer reviews of study documentation and collaborate with project managers to ensure study objectives are met.

Requirements

The role requires experience in monitoring medical device and MedTech studies with a focus on ethical and clinical standards. Candidates must be capable of providing CRA support, conducting co-visits, and managing travel requirements of 25-30%.

About Avania

Industry: Medical Equipment Manufacturing

Company size: 201-500 employees

Avania is the only global CRO built for MedTech — integrating regulatory strategy, clinical development, and market access and reimbursement to take innovations from concept to commercialization with confidence. Avania was purpose-designed to serve medical technology innovators, combining regulatory, clinical, engineering, and market access expertise to guide products across the full lifecycle. We bring deep experience across a wide range of therapeutic areas, with particular strength in cardiovascular, neurovascular, and orthopedics: three of MedTech’s most complex and high-growth fields. Avania combines international reach with deep local expertise. Our regional teams understand the regulatory, cultural, and operational nuances that accelerate approvals and improve site engagement worldwide. Partner with Avania and experience the difference of a MedTech-only CRO: trusted expertise, collaborative engagement, and proven results.

Added 1 months ago