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Medical Governance Human Subject Research

For one of our clients located in the Walloon Brabant, we are urgently looking for a Medical Governance Human Subject Research.

Job Description

As Medical Governance Human Subject Research, you support specific projects within medical governance in accordance to the relevant laws and regulations and POL framework, in a consistent approach within Vaccines.

Responsibilities

  • You provide expertise, project and operational support to the functioning of medical governance projects :
    • You support medical governance initiatives and resolution of medical governance issues relating to the conduct of Human Subject Research in accordance with applicable ethical standards and international guidelines.
    • You ensure appropriateness and readiness of projects submitted to governing committees within Medical Governance
    • You ensure that effective meetings management practices (e.g. agendas, minutes, actions plan and agreements) are adopted by customers. You support tracking and follow-up of recommendations made by governing bodies.
    • You provide transversal perspective across projects by maintaining a global view on development programs for vaccines and ensuring liaison and alignment of recommendations/decisions between departmental and/or cross departmental governing committees.
    • You develop and share expertise in operational governance tools and methodologies, including project and change management, to build capabilities through best practices sharing platform for Leaders in R&D. You optimize shared services to align with customer's needs.
  • Support or facilitate identification of departmental and/or cross departmental business/ consultation needs across Vaccines R&D :
    • You advise the Vaccines R&D Stakeholders on Medical Governance matters. You are recognized as preferred counterpart. You develop and enhance a culture of Medical Governance that will value empowerment, performance and compliance in the context of the conduct of human research.
    • You support the communication of best practices resulting from resolved issues and implementation of best practices
    • You provide integrated project management/change management support for follow-up of HSR medical governance/CMO office actions.
    • You operate risk evaluation /prioritization and propose strategies to meet overall timeline goals. If applicable you define, develop and follow-up KPIs.
  • SupportCMO office :
    • You support the Medical Governance Head for HSR to ensure oversight for HSR
    • You ensure that Vaccines CMO office has timely and regular documentation for:
  • R&D compliance with POLs
  • Governance systems and processes (cross-departmental, central and regional)
  • Issue escalation and management

Requirements

  • You have a University degree in life sciences;
  • You demonstrate a broad scientific background with at least 5 years of experience in clinical research and/or clinical safety in pharmaceutical industry or academic field including at least 1 to 3 years direct experience in Operations and/or Project Management;
  • You have experience in Human Research AND Biobank Management AND GDPR.
  • You have an advanced knowledge of ethical requirements for the conduct of human subject research (GCP, CIOMS, Volume 10) is an asset;
  • You have excellent knowledge and experience in Bioethics (e.g. Belmont report);
  • You have excellent skills in project management and team/meeting facilitation;
  • You have a proven ability to communicate and negotiate effectively at all levels of management. You also have the ability to work with remote teams using effective networking;
  • You possess an excellent knowledge of English, verbally and in writing;
  • You have strong networking capabilities;
  • You have a proven ability to plan, manage and support-functional business/process improvement projects to obtain desired business objectives;
  • You have a proven ability to communicate and negotiate effectively with all levels of management. Also, you are able to work with remote teams using effective networking to build alliances and influence across departmental, national and cultural boundaries;
  • You are positive, with a team spirit and interpersonal skills;
  • You are able to operate with a high level of autonomy; good judgement in terms of knowing when and from whom to seek input;
  • You have an excellent knowledge of clinical business;
  • You have good competence in IT.
  • You have the ability to manage complex situations in which simplifying issues to enable all parties to play their roles in achieving progress is key
  • You have the ability to work in complex change management environment
  • You exercise leadership in a non-hierarchical context, you negotiate and influence at different levels of the organization
  • You understand processes and procedures involving both multi-disciplinary and geographically remote partners on a project level
  • You quickly and accurately understand the organization, inputs and outputs of all of the Vaccines departments.
  • You have a broad knowledge of Vaccines/or other pharmaceutical company business and scientific environment.
  • You have sufficient influence, without positional power, to gain trust and support within Vaccines new projects and support issues resolution.
  • You assume human relations roles as facilitator, consultant, negotiator and trainer.
  • You are able to work fully autonomously.
  • You demonstrate Governance & Compliance.