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    Clinical Manager

    Human Xtensions is a rapidly growing startup, developing breakthrough technology in the field of robotic Minimally Invasive Surgery (MIS). We are looking for somebody to Manage and overlook clinical activities with respect to the company, clinical investigators, customers and patients. Come join our dynamic Sales and Marketing team that is reshaping MIS globally.

    Reports to VP Global Marketing & Sales

    • Develop and deliver appropriate Global clinical strategy (e.g., Global Strategic Marketing, Medical Affairs, Preclinical, Regulatory Affairs, R&D, etc.), ensuring cross-functional alignment
    • Responsible for delivery of assigned clinical projects (delivery on time, within budget and in compliance with regulations and SOP)
    • Establish a kol supportive community, ensure input and strong alignment from KOL leads and other strategically important countries/regions
    • Manage HX medical advisory board- relationship, meeting, workshops, feedback etc.
    • Develop clinical strategy (killer application or other approach) including protocols, end points, clear value proposition.
    • Oversee the implementation of Clinical Research Creating and writing trial protocols, and presenting these to steering committee
    • Lead in appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, CERs etc.
    • Contribute to clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc.
    • Responsible for team’s interface and collaboration with key opinion leaders, investigators, Regulatory Agencies, societies, associations, etc.
    • Be a Subject Matter Expert in the development of clinical evidence
    • Maintaining and communicating a deep understanding of the portfolio and develop competitive intelligence in our product space. Ensuring effective objective value propositions are developed and articulated for Robotic to stakeholders (patients, health care providers, payers, government agencies, health technology assessment organizations, public) through appropriate channels
    • Identifying, evaluating and establishing trial sites, and closing sites down on completion of trial.
    • Liaise with ethics committee regarding rights, safety and well-being of trial subjects.
    • Conducting regular site visits, coordinating project meetings and writing visit reports.
    • Implementing action plans for sites not meeting expectations.
    • Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
    • Ability to collaborate across different functional areas within clinical research and development to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives is preferred.

    Must Have: Minimum Requirements

    • Bachelor’s degree
    • 2+ years experience as a Clinical Research Associate.
    • Knowledge of laparoscopic surgery clinical and industry
    • Knowledge of FDA /CE regulations and their practical implementation
    • Strong verbal and written communication skills in English.
    • Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations is required.
    • Comprehensive understanding of clinical trial regulations across multiple regions is required.
    • Proficient with Microsoft Office Word, Excel and Power Point.
    • Available to travel extensively and on short notice, and ability to manage travel schedules, such as flight schedules.
    • 5+ years of experience in the medical device, pharmaceutical, biotechnology or diagnostics industry
    • Experience in clinical research and regulatory affairs, specially related to the launch of high complex technology in US and OUS
    • Ability to collaborate across different functional areas within clinical research and development to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives is preferred.
    • Excellent communicational skills with physicians/surgeons /OR staff

    Nice to Have: Preferred Requirements

    • Robotic Surgery experience
    • Advanced scientific degree M.Sc. (PhD, MD, Pharma D)

     

     

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