Risk Manager Medical Devices jobs

We are looking for a proactive and detail-oriented Clinical Project Manager to oversee local and international clinical studies. Reporting to the Clinical Operations Manager, you will be the driving force behind our study teams, ensuring that every project is delivered on time, within budget, and in full compliance with global regulatory standards.

The Role:
As a Clinical Project Manager, you will manage the full lifecycle of clinical investigations. You will lead internal study teams, collaborate across functional areas to solve complex operational issues, and maintain high-quality relationships with our Sponsors and Vendors.

Key Responsibilities:

• Project Leadership: Lead the study team, organize kick-off meetings, and act as the primary point of contact for Sponsors and Investigators.
• Operational Oversight: Manage trial timelines, budgets, and vendor deliverables. You’ll oversee IMP/MD supplies and study materials to ensure seamless site operations.
• Quality & Compliance: Ensure all study documentation is filed correctly in the TMF/eTMF. You will review site reports and ensure monitoring activities align with the Monitoring Plan.
• Site Management: Oversee the site feasibility and qualification process. When necessary, you may conduct site visits (SIV, MV, COV) and perform co-monitoring visits with CRAs.
• Risk Management: Proactively identify potential project risks and implement timely solutions to keep enrollment curves and milestones on track.
• Financial Tracking: Forecast resource needs, review vendor invoices, and ensure all billable activities are captured accurately.

What You Bring:

• Education: A University degree in a scientific field.
• Experience: A minimum of 2 years of prior experience as a Clinical Research Associate (CRA). Previous experience in project coordination is highly valued.
• Technical Knowledge: Excellent command of ICH-GCP and ISO 14155 standards.
• Skills: Strong ability to manage and coordinate resources independently. You should be adept at overseeing the activities of CRAs and internal study staff.
• Communication: Fluent in English (written and verbal) with the ability to provide clear, efficient updates to international stakeholders.
• Flexibility: Willingness to perform on-site monitoring visits as a backup or for quality oversight when required.

What we offer:

We offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.

At OPIS, you’ll join a collaborative international team where initiative and growth are encouraged.
If you’re ready to build your career in business development within the clinical research industry — we’d love to hear from you!

Who we are:

OPIS is an International CRO with 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.

OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.

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