We are looking for a self-starting, independently working Start-up Project Manager with a broad skill set to join the Project Management Team in the planning and set-up of projects within scope and budget and compliant with ICH-GCP guidelines, protocol and SOPs.
You will be based at our headquarters in Zeist or home-based anywhere in the EU. As part of our Project Management Team (15 people), you will directly report to a (Associate) Project Director.
Tasks and responsibilities
- Lead the cross-functional team during study start-up phase liaising directly with the Project Manager, core team members, local regulatory experts and the client;
- Serve as client’s contact for start-up processes and oversight;
- Monitor and control start up project schedule, budget, and scope;
- Proactively engage in both quality assurance and risk management planning activities to ensure project deliverables are met. Initiate improvements to enhance the efficiency and the quality of the start-up work performed on assigned projects;
- Develop study-specific documentation (in cooperation with the Compliance department);
- Report the progress made to the sponsor, the next level internally, and the MT;
- Provide input to proposals and budgets and play a role in bid defense meetings.
The ideal candidate has:
- Academic level of education, preferably in the biomedical field;
- A minimum of 6 years’ experience with Clinical Trials in the pharmaceutical and/or CRO industry and CRO experience is preferable;
- Preferably a minimum of 3 years’ experience as a Start-Up Lead or Project Manager;
- Extensive multi-national study experience;
- Excellent command of written and spoken English;
- Excellent knowledge of legislation and regulations and ICH-GCP guidelines.
Furthermore, we are looking for a candidate with the following well developed skills and competences:
- Analytical and social skills and flexibility;
- Accuracy, self-motivating, self-starting, decisive with minimal supervision;
- Ability to work on several projects, retaining timelines and quality;
- The competences related to this function are: ownership, impact, overview, customer orientation, leadership, style flexibility, organizational sensitivity and financial awareness.
Our company culture can best be described as dynamic, open, co-operative, motivational, collegial, and inspirational. We set clear goals, work hard to attain them, and celebrate our successes