Note: The job is a remote job and is open to candidates in USA. Medartis is a medical device company specializing in surgical fixation solutions for orthopaedics and cranio-maxillofacial applications. The Clinical Research Manager will manage clinical research projects, study sites, investigators, regulatory processes, documentation, data collection, and support for studies that meet regulatory and FDA clearance requirements.
Responsibilities
- Cultivate a portfolio of clinical research projects and a network of clinical research sites and investigators to support Medartis business and regulatory requirements
- Create new and maintain existing customer contacts to include visits, trainings and advice acting as the point of contact between internal and external partners
- Create new and maintain existing processes within the Medartis quality system ensuring that all processes comply with internal and external regulatory and legal requirements
- Select and support preclinical and clinical studies (including patient registries, retro- and prospective studies, case study reviews, pre-clinical modeling, possible PMA studies, etc.) by
- Proactive engagement of study institutions and clinical researchers to participate in studies
- Directing communication with the study director from the conception phase until publication of the final report
- Providing support with
- Writing of study protocols contractual questions and follow up as required
- Regulatory requirements (lRB, ethics committees, ICH-GCP, ISO 14155, SAE reporting)
- Statistical analysis and scientific writing (written reviews for publication/ presentations)
- Implementation of digital tools such as databases, EDC solutions, registries, (e)CRFs, etc. and training of study staff (nurses, PIs, etc.) on said tools
- Supplying study hardware
- Coordination with CROs
- Preparation and maintenance of TMF and ISF
- Support of study site(s) and study nurse(s); e.g., with questions relating to data entry
- Visits and/or on-site monitoring of study sites
- Timely communication with all relevant regulatory bodies/lRBs
- Study follow up and data collection with
- Responsible for the complete development of study protocols that meet FDA clearance standards, maintain the continuum of support documentation to further validate the proper ‘Indications for Use' via education and training on the future and existing Medartis product offerings
Skills
- Conscientious, careful, punctual, and reliable work approach
- Fast comprehension and ability to quickly familiarize oneself with new subject areas
- Can work independently and motivated in a small group of specialized experts
- Willingness to take initiative and act autonomously
- Demonstrates assertiveness and patience in daily work
- Relationship development in settings of the field, labs, conferences, or dinner meetings
- Conscientious, precise communication
- Familiar with logistical and regulatory issues in the field of clinical studies
- Proficient in office applications
- Scientific, structured, rigorous, and strategic work approach
- Willingness to travel (up to 20%)
- Degree in a STEM field at a university level or equivalent professional experience/training; PhD and GCP certificate desirable
- Familiarity with the field of orthopedic surgery or orthopedic medical device design preferred
- Knowledge of statistics is advantageous
- Familiarity with EDC software solutions is advantageous
- Fluent (spoken and written) in English, other languages are advantageous
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