Senior Manager Clinical Operations
Netherlands, North Brabant, Eindhoven
Fulltime: 40 hrs a week / € 6000 - 8000 per month
Experience: From 2 years
Medical devices
Introduction
Lead the execution and continuous improvement of clinical operations activities that directly contribute to the successful development and market introduction of innovative healthcare products. In this role, you will combine people leadership, operational excellence, and strategic clinical study management to ensure high-quality clinical evidence generation.
What are you going to do
Clinical Operations Leadership & Team Management
- Lead, coach, mentor, and develop a high-performing Clinical Operations team.
- Manage employee selection, performance management, compensation processes, and career development activities.
- Set clear objectives, KPIs, and expectations while providing regular feedback and recognition.
- Foster an engaging, collaborative, and motivating work environment that supports employee development and retention.
- Ensure operational excellence through effective team leadership and resource management.
- Direct the strategic planning and execution of clinical studies to generate robust evidence supporting product development and commercial success.
- Ensure studies are conducted in accordance with regulatory requirements, company procedures, budgets, timelines, and quality standards.
- Allocate resources effectively to support study execution and optimize project delivery.
- Oversee study progress and proactively address risks, challenges, and operational bottlenecks.
- Ensure adherence to global clinical processes and procedures through training, development, and continuous improvement initiatives.
Regulatory Compliance & Quality Oversight
- Act as a subject matter expert on ICH-GCP, ISO, FDA, and other applicable regulatory requirements related to clinical research involving human subjects.
- Ensure compliance with global clinical research legislation and regulatory expectations.
- Oversee audit requests, responses, effectiveness checks, and corrective actions.
- Share best practices and regulatory expertise related to clinical evaluations, clinical trials, safety assessments, product development, and post-market activities.
- Drive continuous improvement initiatives to strengthen compliance and operational effectiveness.
- Lead cross-functional collaborations with Clinical, Medical, Regulatory Affairs, R&D, Quality, HEMAR, Biostatistics, Data Management, Clinical Development, and other internal stakeholders.
- Manage supplier and vendor relationships to ensure successful study execution and operational performance.
- Provide strategic guidance and insights to senior leadership and executive stakeholders.
- Support organizational objectives by aligning clinical research activities with broader business strategies.
- Identify opportunities to improve clinical development processes, drive innovation, and enhance organizational capabilities.
Essential skills and knowledge
- A Bachelor's or Master's degree in Life Sciences, Biomedical Sciences, Healthcare, Pharmacy, Clinical Research, or a related field.
- A minimum of 5-10 years of experience in Clinical Operations within a regulated environment.
- At least 5 years of Clinical Operations Management and people management experience.
- Experience within the medical device, pharmaceutical, biotechnology, or healthcare industry.
- Profound knowledge of clinical research legislation and ICH-GCP guidelines.
- Experience with Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), document management systems, and Microsoft Office.
- Demonstrated experience in project management, budget management, vendor management, and regulatory compliance.
- Strong knowledge of clinical study management, clinical site management, document auditing, and quality systems.
- Excellent communication and stakeholder management skills in English.
What we offer
- A competitive gross monthly salary based on your experience and expertise.
- 8% holiday allowance.
- Travel allowance and business-related expenses reimbursement.
- Laptop and mobile phone.
- 26 vacation days, with the possibility to expand.
- Flexible and hybrid working opportunities.
- Extensive training and career development opportunities through the Brunel Academy.
- A pension scheme and collective health insurance.
- Discounts on fitness memberships, cultural activities, and vitality programs.
About Brunel
Brunel Engineering connects highly skilled specialists to leading organizations within Life Sciences, Healthcare, High Tech, Manufacturing, and Industrial sectors. We offer challenging projects that enable professionals to continuously develop their expertise while contributing to innovative solutions.
Brunel offers outstanding professionals a diverse and challenging career in an organization where an open, professional, and supportive culture is highly valued. Personal initiative is recognized and rewarded, and you will receive the coaching, training, and support needed to achieve your career ambitions.