Project Manager

Projects and Services is looking for one Project Manager (PM) to reinforce its team.

The Project Manager works under the hierarchical supervision of the Projects Director.

Objective

The Project Manager (PM) is responsible for planning, monitoring and controlling multiple oncology clinical trials and/or research projects, from project initiation to completion. The PM ensures that project objectives are achieved and oversees trials to ensure they are conducted ethically, efficiently, with a strong focus on patient safety and data integrity.

The PM leads the project team functionally and manages communication with internal stakeholders (e.g. Project team members, other PMs, Heads of departments) and external stakeholders (e.g. upstream partners, vendors, intergroups, study coordinators).

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.

Benefits

30 days holidays (full time)

Wage according to our Non\-Profit organisation status

Hospitalisation insurance and ambulatory care

Free parking

Hybrid working environment (from Belgium only)

Reimbursement of public transport

Meal vouchers

Pension plan

Permanent contract

Homeworking allowance

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