Main responsibilities / Major Activities

• Trial planning and set-up
  Manage multiple clinical trials and research projects, ensuring all activities and deliverables are clearly defined, scheduled, and meet budget and quality targets.
  Develop comprehensive project management plans, detailing tasks and responsibilities, schedules, and budget.
• Trial execution &oversight
  Oversee project execution to ensure deliverables are completed on time, within budget, and to the expected quality.
  Monitor progress and proactively address deviations or risks
• Stakeholder management
  Manages project’s external stakeholders including communication, contractual commitments and budget. Serve as the project primary point of contact for Upstream partners.
• Team Leadership
  Leads, motivates, and coordinates the project team ensuring effective transversal coordination.
  Collaborate with Department heads to secure adequate project staffing.
• Quality & Compliance
  Ensure adherence to ICH GCP E6(R3) and EORTC policies and procedures
  Ensure high-quality documentation in CTMS and eTMF systems
  Prepare for and support audits and inspections
  Contributes to improving project management processes within Projects Direction
• Risk Management
  Integrate risk-based quality management and Quality-by-Design principles throughout the project lifecycle
  Facilitate risk identification, assessment and management within the study team
• Change Management
  Anticipate project’s changes with internal and external stakeholders.
• Internal communication
  Maintain clear communication and alignment with internal stakeholders, including reporting and escalation of issues when needed.
• Mentorship
  Provides guidance and mentorship to newcomers.

Major Activities

• Develop study budget and timelines during the study initiation phase
• Document study management, communication, risk and TMF management in study plans
• Engage with upstream partners (e.g. industry partners, grant providers)
• Oversee contract set-up with providers and collaborating groups
• Coordinate study team activities from initiation to study close-out, including
  • Leading project-based meetings and risk review sessions,
  • Overseeing study team training
• Monitor project deliverables, budget, timelines, quality, risks and change requests
• Report progress using Dynamics and other management tools
• Manage trial close out activities and ensure proper documentation archiving

Profile

Education & experience

• Minimum education requirement: master’s degree in sciences, pharmacy or management.
• Minimum 5 to 7 years’ experience in a project management in highly scientific environment or in operations role in the field of clinical trials.

Knowledge & technical skills

• Solid understanding of ICH GCP E6(R3), and clinical trial regulation
• Experience with CTMS, eTMF, and EDC systems,
• knowledge of Project Management areas (PMI), PMP certification is a plus
•  Fluency in English (spoken, written) is required.

Soft skills:

•  Team player with strong leadership skills, using open communication and influencing skills to work effectively within teams and across functions
•  Financial acumen, understanding financial principles for budgeting and forecasting.
•  Open minded profile, with strong desire to learn and with the ability to work in a multilingual and multicultural environment.
•  Strong negotiation skills are a plus for contract management and external stakeholders’ management.