About the Company:

Our client is a Medical Device company specializing in interventional radiology, vascular surgery, interventional cardiology, and oncology devices. Their products are trusted worldwide for quality and innovation, helping to improve patient care through image-guided procedures. The organization prides itself on fostering a collaborative, mission-driven culture that emphasizes excellence and patient-centered solutions.

Role Overview

As the Manager, Clinical Operations, you will be responsible for overseeing all clinical activities within a portfolio of studies, both pre-market and post-market. You will lead a team of Clinical Affairs Managers and drive the execution of global and local clinical trials while ensuring compliance with regulatory standards and Good Clinical Practice (GCP).

This role combines leadership, strategy, and execution, providing an excellent opportunity for professionals who thrive in fast-paced, collaborative environments.

Key Responsibilities:

• Leadership: Oversee clinical activities for a portfolio of pre-market and post-market studies. Manage and mentor a team of Clinical Affairs Managers, ensuring projects are executed effectively.
• Execution: Direct local and global clinical research projects, collaborating with cross-functional teams and external stakeholders. Ensure compliance with regulatory requirements, Good Clinical Practice (GCP), and company policies.
• Documentation & Strategy: Develop and manage clinical study protocols, reports, and budgets. Provide expertise in clinical trial design, global clinical strategy, and execution.
• Collaboration: Build and maintain strong relationships with internal and external stakeholders, including investigators, authorities, and Contract Research Organizations (CROs).
• Audit & Compliance: Represent the clinical research team during audits and ensure projects adhere to relevant guidelines and standards.

Your Skills & Qualifications:

• Bachelor’s degree in life sciences, engineering, or a related field (advanced degree preferred).
• Minimum of 7 years of Clinical Research experience, with at least 5 years in management roles.
• Certification through ACRP or SOCRA.
• Expertise in medical device clinical trials, preferably in interventional radiology or cardiovascular fields.
• Proven experience managing budgets and leading clinical teams.
• Strong knowledge of GCP and regulatory compliance.
• Ability to travel up to 40%.