Senior Clinical Operations Consultant - Medical Devices (F/M/X)

Job description

As a Senior Clinical Operations Consultant, you will play a key leadership role in delivering clinical operations expertise across a diverse portfolio of medical device projects. Working within multidisciplinary teams, you will provide strategic oversight, operational leadership, and regulatory guidance to ensure successful clinical study execution while contributing to the growth of our consulting practice.

Key Responsibilities

Clinical Operations Leadership

Lead the planning, execution, and oversight of clinical studies throughout the study lifecycle, ensuring delivery of high-quality clinical evidence.

Provide strategic direction for clinical operations activities supporting product development, regulatory submissions, and post-market clinical evidence generation.

Ensure studies are conducted in accordance with applicable regulations, international standards, Good Clinical Practice (ICH-GCP), ISO 14155, FDA requirements, and internal quality processes.

Identify operational risks and implement mitigation strategies to maintain study quality, timelines, and budgets.

People Leadership

Lead, coach, mentor, and develop Clinical Operations professionals across project teams.

Set clear objectives, monitor performance, provide regular feedback, and support career development.

Foster a collaborative, high-performing, and inclusive working environment that encourages continuous learning and professional growth.

Support talent acquisition, onboarding, and capability development within the Clinical Operations practice.

Project & Portfolio Management

Manage multiple clinical programs and priorities simultaneously across various medical device projects.

Allocate resources effectively to optimize project delivery while balancing quality, timelines, and budget expectations.

Monitor project progress, KPIs, budgets, and operational performance, proactively addressing challenges and escalating risks when appropriate.

Drive operational excellence through efficient planning, execution, and governance.

Regulatory & Quality Excellence

Act as a subject matter expert in clinical research regulations and industry best practices.

Provide guidance on ICH-GCP, ISO 14155, FDA regulations, MDR/IVDR, and other applicable global regulatory requirements.

Support audit readiness, inspection preparation, CAPA activities, and quality improvement initiatives.

Ensure documentation, clinical systems, and study records comply with regulatory and quality standards.

Cross-functional Collaboration

Partner with multidisciplinary teams including Regulatory Affairs, Clinical Development, Medical Affairs, Quality, Biostatistics, Data Management, Safety, R&D, and external partners to achieve project objectives.

Build strong relationships with internal and external stakeholders while providing strategic clinical operations expertise.

Present project updates, operational insights, and strategic recommendations to senior leadership.

Continuous Improvement

Identify opportunities to improve clinical development processes, systems, and operational efficiencies.

Lead or contribute to initiatives focused on standardization, innovation, digital transformation, and best practices in clinical operations.

Promote knowledge sharing and provide training on clinical operations processes and regulatory requirements.

Required Qualifications

Education

Bachelor's or Master's degree in Life Sciences, Biomedical Sciences, Nursing, Pharmacy, Medical Technology, or a related scientific discipline.

Experience

5–10 years of experience in Clinical Operations within the medical device, pharmaceutical, or other highly regulated healthcare industry.

Minimum 5 years of experience leading clinical operations teams and managing people.

Demonstrated experience managing clinical studies from planning through study close-out.

Experience working in a consulting,