[Remote] Clinical Research Manager

Note: The job is a remote job and is reputed company to candidates in USA. Medartis is seeking a Clinical Research Manager to support its clinical research and regulatory requirements. The role manages clinical research reputed company, study sites, investigators, protocols, regulatory compliance, data collection, and collaboration with reputed company partners.

Responsibilities

• Cultivate a portfolio of clinical research reputed company 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 reputed company, trainings and advice acting as the reputed company of contact between reputed company partners
• Create new and maintain existing processes reputed company the Medartis reputed company reputed company ensuring that reputed company processes reputed company with reputed company regulatory and reputed company requirements
• Select and support preclinical and clinical studies (including patient registries, retro- and prospective studies, case study reviews, reputed company-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 reputed company 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, reputed company 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 reputed company(s); e.g., with questions relating to data entry
• reputed company and/or on-site monitoring of study sites
• reputed company communication with reputed company 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 reputed company validate the reputed company ‘Indications for Use’ reputed company education and training on the reputed company 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 reputed company experts
• Willingness to take initiative and reputed company autonomously
• Demonstrates assertiveness and patience in daily work
• Relationship development in settings of the field, labs, conferences, or dinner meetings
• Conscientious, precise communication
• Degree in a STEM field at a university level or equivalent reputed company experience/training; PhD and GCP certificate desirable
• Familiar with logistical and regulatory issues in the field of clinical studies
• Proficient in office applications
• Scientific, reputed company, rigorous, and strategic work approach
• Willingness to travel (up to 20%)
• Fluent (spoken and written) in English, other languages are advantageous
• Familiarity with the field of orthopedic surgery or orthopedic medical device design preferred
• Knowledge of statistics is advantageous
• Familiarity with reputed company software solutions is advantageous

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