Clinical Study Manager
NAMSA
Beijing, China
1小时前

NAMSA pioneered the industry, NAMSA was the first independent company in the world to focus solely on medical device materials for safety.

NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry.

We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization whose :

  • Mission is to make a scientific contribution to every medical device in the world.
  • Culture is passionately committed to the partnership between one another and our clients to improve and save lives through a respectful, trusting, and collaborative environment.
  • Values have stood the test of time.
  • Above all else, conduct ourselves with integrity
  • Job Description :

    Principal Duties and Responsibilities

    General Duties and Responsibilities

  • Establishes and ensures schedule, budget and quality commitments are met for the client.
  • Manages (motivates, communicates) internal team members.
  • Understands investigational product(s) including high-level understanding of the Medical Device Development Process.
  • Handles challenging situations, and knows when to call-in help.
  • Interacts as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
  • Performs project in compliance with regulations.
  • Delivers presentations, including preparation, assembling slides, and speaking.
  • Provides feedback regarding project team members using the appropriate performance management tools and processes, in a timely manner.
  • Senior Clinical Study Manager

    In addition to the items listed above :

  • Effectively manages cross-functional projects.
  • Principal / Senior Principal Clinical Study Manager

  • In addition to the items listed above :
  • Proposes and implements systems to support internal improvement and NAMSA’s long-term growth.
  • Marketing Duties and Responsibilities

  • Participates in meetings with prospective clients.
  • Provides scope of project and relevant information to support the creation of proposals.
  • Identifies opportunities to bring in new projects / clients.
  • Offers opportunities to clients for expansion of MRO services to be provided by NAMSA.
  • Senior, Principal and Senior Principal Clinical Study Manager

    In addition to the items listed above :

  • Speaks at conferences, webinars, or other marketing venues.
  • Role-Specific Duties and Responsibilities

  • Uncomplicated clinical study design and clinical protocol development.
  • Leads straightforward multidisciplinary (stats, DM, clinical) US and OUS clinical projects.
  • Clinical site selection and qualification.
  • Clinical site initiation and training.
  • Clinical monitoring plan development.
  • Clinical monitoring strategy; troubleshoots site and team issues.
  • If needed, independently performs qualification and monitoring visits and writes follow-up reports.
  • Follows up and closes (whenever possible) issues / action items found during monitoring. Tracks and manages enrollment;
  • troubleshoots enrollment challenges.

  • Assists team members in managing challenging investigators / staff.
  • Provides oversight of team members to ensure regulatory and monitoring documents are audit-ready throughout conduct of study.
  • Manages development of a simple clinical study report.
  • Conducts and summarizes literature searches according to applicable US and EU requirements.
  • Assists in planning and conduct of site and sponsor clinical audits (Pre-BIMO).
  • Assists with FDA CRO inspections of NAMSA.
  • Organizes and manages Investigator Meetings.
  • Selects and manages Core Laboratories.
  • Safety committee (e.g. DSMB or CEC) selection and management.
  • Works with data management to develop systems for and track project metrics.
  • Works with data management / biostatistics to develop reports and listings for centralized review of data; reviews data, spots trends to ensure quality of data.
  • Travels as needed (typically between 20-30%) to meet project milestones.
  • Senior Clinical Study Manager

    In addition to the items listed above :

  • Moderately complex clinical study design and clinical protocol development.
  • Leads moderately complex multidisciplinary (stats, DM, clinical) US and OUS clinical projects.
  • Performs as lead auditor for site and sponsor clinical audits (Pre-BIMO).
  • Identifies and implements solutions to accelerate enrollment.
  • Manages a moderately complex clinical study report.
  • Interacts directly with FDA.
  • Negotiates with regulatory agencies and clients.
  • Principal Clinical Study Manager

    In addition to the items listed above :

  • Complex clinical study design and clinical protocol development.
  • Leads complex multidisciplinary (stats, DM, clinical) US and OUS clinical projects.
  • Manages a complex clinical study report.
  • Develops strategy and leads meetings w / FDA.
  • Senior Principal Clinical Study Manager

    In addition to the items listed above :

  • Highly Complex clinical study design and clinical protocol development.
  • Leads complex multidisciplinary (stats, DM, clinical) US and OUS clinical projects.
  • Manages a complex clinical study report.
  • Critically evaluates, analyzes, and interprets complex data and presents in a clear, well organized, scientifically sound report.
  • Develops strategy and leads meetings w / FDA.
  • Qualifications and Skills

    Clinical Study Manager

  • Bachelor’s degree or equivalent experience in a related field, with a minimum 3 years of current monitoring (preferred) and relevant clinical trial experience; and
  • Project management experience.
  • Fluency in English and local language, if different, required.
  • Senior Clinical Study Manager

  • Bachelor’s degree or equivalent experience in a related field, with a minimum 5 years of monitoring (preferred) and relevant clinical trial experience; and
  • Project management experience with at least 1 complex multicenter US / OUS trial.
  • Fluency in English and local language, if different, required.
  • Principal Clinical Study Manager

  • Bachelor’s degree or equivalent experience in a related field, with a minimum 8 years of monitoring (preferred) and relevant clinical trial experience; and
  • Project management experience including at least 3 clinical projects of increasing complexity and at least 1 complex multicenter US / OUS trial.
  • Fluency in English and local language, if different, required.
  • Senior Principal Clinical Study Manager

  • Bachelor’s degree or equivalent experience in a related field, with a minimum 10 years of monitoring (preferred) and relevant clinical trial experience; and
  • Project management experience including at least 7 clinical projects of increasing complexity and at least 1 complex multicenter US / OUS trial.
  • Fluency in English and local language, if different, required.
  • Technical Competencies

  • Knowledge of Good Clinical Practices in US and Europe.
  • Knowledge of regulations that apply to medical device trials at various stages of development (feasibility, pivotal, post-market) and ability to adapt trial oversight accordingly.
  • Familiarity with all aspects of the clinical trial process including, but not limited to protocol, development, site selection / qualification, site initiation, monitoring, close-out, investigator meetings, DSMB / CEC, core lab management.
  • Understanding of site escalation process for compliance issues.
  • Multidiscipline (at least 2 specialties) therapeutic knowledge.
  • Familiarity with medical device development process from pre-clinical to commercialization.
  • Understanding of role of data management and biostatistics in the clinical trial process.
  • Understanding of the type and quality of data needed from a clinical trial and how it should be presented.
  • Ability to effectively communicate with physicians, health care workers, study coordinators, IRB / EC / REB personnel (and to persuade them to do what is needed).
  • Working Conditions

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand;
  • walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and / or move up to 25 pounds.

    Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.

  • Extensive use of a computer keyboard.
  • Position descriptions are not intended, and should not be construed to be an exhaustive list of all responsibilities, skills, and efforts or working conditions associated with a job.

    NAMSA reserves the right to revise duties as needed.

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