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Clinical Study Manager (EU)

  • Lieu:

    Flandre Orientale, Belgique

  • Contact:

    Aurelie Petit

  • Type de poste:

    Contract

  • Téléphone de contact:

    +32 10 68 53 32

  • Secteurs d’activité:

    Life Sciences, Clinical Research

  • Contact E-mail:

    aurelie_petit@oxfordcorp.com

Do you have Study Management experience and would like to be part of a dream team in a growing and exciting Medical Devices company as a Clinical Study Manager ? Apply now!

Job Description

A Clinical Study Manager (CSM) is responsible for the timely execution and high quality implementation of some or all of the following clinical study activities based on project-specific work orders, study complexity and
CSM role-level (e.g., Associate vs. Senior, etc.)


Responsibilities

  • Develops and maintains foundational study materials and tools (protocol with study design, training slides, informed consent, investigator brochure, instructions for use, templates, forms, SOPs, processes, etc.), and coordinates team and client review processes.
  • Creates and manages study tracking tools (metrics, systems, reporting).
  • Supports internal clinical team members: protocol training, client and site management and oversight, escalation and resolution of site issues.
  • In collaboration with Project Management, supports all project-level duties: Establishes and monitors project metric, tracks project deliverables and communicates project status to clients and internal teams
  • Drives all site activities from start-up through close-out
  • Site selection and qualification and site initiation (on-site or remote training, follow-up, activation)
  • IRB/IEC/REB/REC submissions
  • Budget and contract negotiations
  • Monitors notable trends/potential issues in data entry, general site compliance to the protocol, GCP, SOP, and other applicable guidelines, adverse events, protocol deviations
  • Investigator site file maintenance
  • Site engagement activities (recruitment strategies, coordinator calls, newsletters, trainings, etc.)
  • Manages monitoring activities (e.g., scheduling, follow-up, action item resolution, etc.)
  • Supports close-out efforts by ensuring all data and regulatory action items are adequately resolved, investigator responsibilities relayed, IRB/EC reporting complete.
  • Ensures project plans and other TMF level documents are current and consistent
  • Ensures Trial Master File quality and overall audit readiness at study and site levels
  • Assists in the submission and review of all clinical deliverables for regulatory submissions (e.g., FDA, National Competent Authorities, etc.)
  • General project compliance: ensures that adherence to industry standards and regulatory requirements, including but not exclusive to contractual agreements, department guidelines, SOPs, applicable international, Federal and State regulations, and ICH Guidelines.
  • Understands investigational product(s) including high-level understanding of the Medical Device Development Process.
  • Assists in planning and conduct of site and sponsor clinical audits.
  • Assists with FDA/competent authority inspections, sponsor/vendor audits
  • Organizes and manages Investigator Meetings.
  • Selects and manages Core Laboratories.
  • Safety committee (e.g. DSMB or CEC) selection and management.

Requirements

  • Bachelor's degree or equivalent experience in a related field, with a minimum 3 years of relevant clinical trial and/or monitoring experience; and Project management experience.
  • Fluency in English and local language, if different, required.
  • Knowledge of Good Clinical Practices and regulations that apply to medical device trials at various stages of development (feasibility, pivotal, post-market).
  • Understanding of site escalation process for compliance issues.
  • Multidiscipline (at least 2 therapeutic areas) therapeutic knowledge.
  • Familiarity with medical device development process from pre-clinical to commercialization.
  • Ability to effectively communicate with physicians, health care workers, study coordinators, IRB/EC/REB personnel (and to persuade them to do what is needed).
  • Ability to prepare slides and present complex information professionally and clearly; strong speaking skills.
  • Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required.
  • Based in Europe ( with preference in France, Belgium or Spain ) and existing right to work in Europe.

Benefits

  • Fulltime position
  • Open for employee and freelance profiles (at least 80% availability)
  • A balanced salary package based on your capabilities and experience, including extra legal benefits


Vacancy number: 20640