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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Bachelor's or Master's degree in Life Sciences, Biomedical Sciences, Nursing, Pharmacy, Medical Technology, or a related scientific discipline.
- 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, CRO, or multi-project environment is considered an advantage.
- Strong understanding of:
- ICH-GCP
- ISO 14155
- FDA regulations
- MDR/IVDR clinical evidence requirements
- Clinical study management
- Clinical evaluation and post-market clinical follow-up (PMCF)
- Experience with Clinical Trial Management Systems (CTMS)
- Experience with Electronic Data Capture (EDC) platforms
- Knowledge of document management systems and audit processes
- Understanding of clinical quality management and vendor oversight
- Strategic Leadership
- Clinical Operations Management
- Medical Device Clinical Research
- Regulatory Compliance
- People Management & Coaching
- Project & Portfolio Management
- Vendor & Supplier Management
- Budget Management
- Risk Management
- Stakeholder Management
- Continuous Improvement
- Process Optimization
- Decision Making
- Analytical Thinking
- Excellent Communication & Presentation Skills
- Ability to manage multiple priorities in a dynamic consulting environment
- Work on a diverse portfolio of innovative medical device projects across international organizations.
- Collaborate with multidisciplinary experts in Life Sciences and Healthcare.
- Contribute to meaningful healthcare innovations while expanding your expertise across different technologies and therapeutic areas.
- Benefit from continuous learning, career development opportunities, and a collaborative consulting culture.
- Be part of a global consulting organization that values entrepreneurship, innovation, and professional growth.
Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
