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Clinical Study Manager

  • Lieu:

    Bruxelles, Belgique

  • Contact:

    Amandine Planche

  • Type de poste:

    Contract

  • Téléphone de contact:

    +32 10 68 53 30

  • Secteurs d’activité:

    Clinical Research

  • Contact E-mail:

    amandine_planche@oxfordcorp.com

Are you an experienced CRA wishing to step up to a Project Management function? Or do you have already experience in Project Management and wish to expand your experience in one of the best Pharmaceutical companies in the world? Don't hesitate and apply now!

Job Description

As a Clinical Study Manager you will manage and contribute to clinical studies to ensure studies are performed per the necessary regulations and to enable more efficient trial delivery for patients, investigators and clinical site staff. Depending on your background and experience, you are able to take on more leadership tasks.

Responsibilities

  • Execute/Follow up on all study activities prior to site activation until study close out according to standards and aligned with study/project requirements and timelines.
  • In accordance with the overall project plan, establish and maintain accurate study level plans
  • Maintain and analyze study data (metrics) on assigned studies, ensuring optimal efficiency to reduce timelines and identify opportunities for continuous improvement
  • Develop and maintain effective working relationships with, and be the primary contact for key stakeholders
  • Provide input into the development and implementation of drug management, contracts, budgeting, resourcing, source document verification, data flow, case report forms, and safety monitoring
  • Accountable for the development and active management of the study patient recruitment strategies
  • Liaise and collaborate with relevant authorities/bodies to further enhance clinical trial process, government policies/ laws, via innovative approaches
  • Accountable for the selection, training and management of external suppliers
  • Manage the delivery of Study Activities in Order to Meet Study Plans
  • Ensure studies are performed and conducted in compliance with ICH-GCP guidelines, SOPs, local operating guidelines and all applicable regulatory requirements
  • Ensure patient safety and data quality are maintained, and that any concerns are escalated appropriately
  • Ensure data is delivered in accordance with established dataflow timelines
  • Develop/maintain investigator relations, build and maintain a professional relationship between the company and Investigator
  • Contribute to activities to improve and maintain the quality and effectiveness of processes and activities within the function
  • Take ownership for own development
  • Drive patient-centricity throughout clinical operations by always putting the needs of the patient and the investigator and clinical site staff first
  • Proactive stakeholder management and alignment
  • Inspire and empower talent to promote communication and community in a global matrixed environment. Optimizing growth opportunities and capabilities to successfully contribute and operate in a diverse and global environment. Drive new thinking by identifying new opportunities and options to embrace value creation
  • Promote and support quality and compliance by being accountable for GCP/GVP compliance, data integrity, and taking a balanced risk-based approach in the work you are focused on, seeking guidance or direction as needed

Requirements

  • University degree or equivalent; preferably in a medical/science-related field
  • At least 2 years CRA experience or additional PM experience (depending on your background/skills, your level will be determined)
  • Communication: excellent written and verbal communication skills demonstrated by the ability to present clear messages from complex information/data to all levels in the organization
  • Good knowledge in Dutch, French and English (NL/EN + B1-B2 level in FR or FR/EN + B1-B2 level in NL)
  • Open mindset to work on many different tasks to be able to meet study timelines
  • Organizing: demonstrated ability to prioritize and manage multiple tasks, self-motivated and achievement driven
  • Problem-solving skills
  • Leadership, mentoring, coaching skills
  • Working knowledge in own area of expertise, Drug Development and Clinical Operations and best practices
  • Good knowledge of ICH GCP, GPP, SOPs/Guidelines and quality standards related to study management
  • Clinical development experience on the operational aspects of conducting clinical studies
  • Experience of influencing and negotiating at all levels to achieve team delivery
  • Existing right to work in Europe required

Benefits

  • A balanced salary package based on your capabilities and experience
  • long term opportunity
  • full-time position (open for 80%)

Vacancy number: 20010