Medartis seeks a Clinical Research Associate to manage investigator-initiated studies for the APTUS portfolio, ensuring regulatory compliance and serving as a liaison between the company, sites, and partners.
This position is responsible for the execution, coordination, and oversight of clinical studies supporting the APTUS product line. The role acts as a central point of contact between Medartis, external investigators, study sites, and partners, ensuring all activities adhere to regulatory standards, internal procedures, and project schedules.
Responsibilities
- Select and support various study types, including patient registries, retrospective and prospective analyses, case reviews, and pre-clinical biomechanics or technique evaluations.
- Engage proactively with research institutions and clinicians to encourage participation in clinical studies.
- Establish and maintain relationships with customers and partners, providing visits, training, and advisory support.
- Develop and uphold processes within the quality management system to ensure alignment with legal and regulatory mandates.
- Manage communication with study directors from protocol conception through final report publication, including assistance with protocol drafting.
- Address contractual matters and follow up on related issues as needed.
- Deploy digital tools such as databases, EDC systems, and electronic case report forms, while training study staff on their use.
- Provide necessary hardware for study operations.
- Coordinate activities with Contract Research Organizations (CROs).
- Prepare and maintain Trial Master Files (TMF) and Investigator Site Files (ISF).
- Offer support to study sites and nurses, particularly regarding data entry queries.
- Conduct on-site monitoring and visits to study locations.
Requirements
- Bachelor’s degree in a Science, Technology, Engineering, or Mathematics (STEM) discipline.
- At least two years of experience working at a clinical site, CRO, sponsor, or in equivalent professional training.
- Understanding of logistical and regulatory challenges within clinical research.
- Strong proficiency with standard office software applications.
- Fluency in English, both spoken and written.
- Willingness to travel up to 20% of the time.
Nice to have
- Advanced academic degree.
- Background in orthopedic surgery or orthopedic medical device design.
- Knowledge of statistical methods.
- Experience with EDC software platforms.
- Proficiency in additional languages.
What the company offers
- A diverse and responsible role focused on quality and service within a fast-growing international organization.
About the company
Medartis is a global leader in medical devices for surgical bone fixation in extremities and the craniomaxillofacial region. With approximately 1,400 employees across 13 locations, the company distributes its products in more than 50 countries, combining innovative solutions with expert professionals to serve as a preferred provider in orthopaedics.
- Combines innovative solutions with skilled professionals to be the provider of choice in orthopaedics.
- Employs around 1,400 people across its 13 locations and sells its products in over 50 countries worldwide.
How to apply
Documents to submit:
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