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Clinical Manager
PresencialTiempo completoMedical Affairs ManagementMedical Devices
Lead end-to-end pre-market and post-market clinical activities for a medical device platform, including validation, clinical studies, regulatory support, evidence generation, and collaboration with global clinical stakeholders.
Responsabilidades
- Manage clinical project plans, timelines, budgets, milestones, risks, and deliverables from pre-clinical validation through post-market evidence generation.
- Define clinical requirements and provide clinical input to product design and development.
- Plan and lead pre-clinical validation strategies and evaluation activities.
- Lead clinical study strategy, planning, and execution in accordance with protocols, ethical requirements, Good Clinical Practice, regulations, timelines, and budgets.
- Conduct clinical and scientific assessments covering standard of care, clinical trends, mechanisms of action, and emerging technologies.
- Provide clinical rationales, validations, evaluation reports, and development plans for regulatory submissions.
- Generate clinical evidence and support publications, user guidelines, marketing materials, presentations, and training content.
- Collaborate with R&D, product management, marketing, regulatory, quality, clinical training, and commercial teams.
- Develop relationships with key opinion leaders and clinical investigators.
- Communicate project status, risks, mitigation plans, milestones, and decisions to stakeholders.
Requisitos
- Bachelor’s degree in life sciences, biomedical engineering, medical sciences, biotechnology, or a related field.
- At least 5 years of clinical project management experience in the medical device or pharmaceutical industry.
- Hands-on or demonstrated experience with pre-clinical testing, laboratory evaluations, study design, product performance evaluation, or medical device validation.
- Track record of managing clinical studies, validation activities, or multiple cross-functional development projects.
- Strong knowledge of Good Clinical Practice, clinical research regulations, and applicable medical device regulatory requirements.
- Familiarity with medical device quality systems, design controls, risk management, and clinical evaluation documentation.
- Fluent written and spoken English.
- Willingness to travel globally approximately 15%.
Se valora
- Advanced degree in a relevant field.
- Experience supporting marketing, commercial, or scientific communications.
- Experience developing publications, white papers, clinical summaries, or training materials.