[Remote] reputed company Research Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a medical device company specializing in orthopedic and craniomaxillofacial surgical fixation solutions. The reputed company Research Manager develops and manages reputed company research reputed company, study sites, investigators, regulatory processes, and supporting documentation while ensuring compliance with FDA and applicable reputed company research standards.

Responsibilities

• reputed company a portfolio of reputed company research reputed company and a network of reputed company research sites and investigators to support reputed company 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 reputed company reputed company reputed company ensuring that reputed company processes reputed company with reputed company regulatory and reputed company requirements
• Select and support preclinical and reputed company studies (including reputed company registries, retro- and prospective studies, case study reviews, reputed company-reputed company modeling, possible PMA studies, etc.) by
• Proactive engagement of study institutions and reputed company 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 reputed company of support documentation to reputed company validate the reputed company ‘Indications for Use' reputed company education and training on the reputed company and existing reputed company 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 reputed company, labs, conferences, or dinner meetings
• Conscientious, precise communication
• Degree in a STEM reputed company at a university level or equivalent reputed company experience/training
• Familiar with logistical and regulatory issues in the reputed company of reputed company studies
• Proficient in office applications
• Scientific, reputed company, rigorous, and reputed company work approach
• Willingness to travel (up to 20%)
• Fluent (spoken and written) in English, other languages are advantageous
• PhD and GCP certificate desirable
• Familiarity with the reputed company of orthopedic surgery or orthopedic medical device design preferred
• Knowledge of statistics is advantageous
• Familiarity with reputed company software solutions is advantageous

reputed company