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Senior Clinical Research Associate
hace 3 semanas
**About Straumann Group**
Straumann Group has been a leader in premium implants for the last 75 years, followed by becoming one of the largest player in entire Implantology market with the 4 more brands acquired over more than a few decades. The expansion into Orthodontics and digital dentistry has been a focus area for the company over the recent years to establish as a oral care company in specialty dentistry. As the company prepares for its rather ambitious 5B Goal, making commercial business models in Specialty workflows is the way chosen to become the Experience company focused on patient in the center of all innovation.
**About the job**
We are looking for you as our new Senior Clinical Research Associate (M/F/x). This role (100%, 40hrs/week) includes every aspect of clinical trials on medical devices across the entire study duration to generate high-quality evidence for our entire portfolio. Your workplace is at Straumann group’s Southern European Hub located in Madrid, Spain. You will be reporting into the Global Clinical Research Portfolio and Data Team, located at Headquarters in Basel, Switzerland.
**Key Responsibilities**:
- Works in compliance and conformity with ISO/GCP Guidelines, the Declaration of Helsinki, SOPs and applicable legal and regulatory requirements
- Supervises internal and outsourced monitoring activities during all phases of the study
- Supports Study Management with
- Maintaining study documents, in particular the electronic TMF
- Maintaining the Clinical Trial Management System
- Communication with IRB/EC and RA, if applicable (e.g., annual safety reports, protocol deviations, SAEs, amendments)
- Handling Adverse Event reporting
- Administrating contracts and study budget
- Prepares reports to IRB/EC and RA, if applicable
- Education in relevant field ((dental) medicine, life sciences, engineering, material sciences, etc.)
- Relevant work experience in clinical research
- Relevant experience in monitoring, preferably in device studies
- Fluent in written and spoken English
- Excellent communication and interpersonal skills
- Dynamic and self-motivated person, comfortable working in a matrix environment
- Distinct customer orientation both internally and externally
- Team player
- Willingness to travel (approx. 20%)
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
**Employment Type**:Full Time
**Alternative Locations**:Spain : Madrid
**Travel Percentage**:0 - 20%
**Requisition ID**:16807
