Vacancy Project Compliance Manager – Zeist
8 JUN ’22: For a young and strongly growing organisation in the clinical trial field, we are looking for a Project Compliance Manager. The organisation distinguishes itself in combining the latest scientific insights with operational excellence to develop innovative solutions, enabling clients to bring their treatments to the market faster.
As a Project Compliance Manager, you will be focused on ensuring compliance with regulatory and quality requirements/standards by providing structured advice to different parties within the organisation. In this position, you will be the go-to person for when project managers or team leads are in need of a fresh pair of eyes to get them back on track. Due to your experience within the clinical field focussing on clinical trial processes, tools, reports and systems across different clinical trials you make yourself indispensable to your colleagues. Besides, part of this opportunity also includes training CRAs on the correct implementation of certain processes to ensure compliance during the clinical trials.
This position is one in which energy, pro-activity and accuracy are highly beneficial when constantly interacting with people in- and outside the organisation. Besides this role entails:
- Developing project-specific clinical trial processes;
- Ensuring correct implementation of clinical trial processes;
- Act as primary contact for escalation of any obstacles/issues for all involved parties;
- Review project-specific plans and proposed clinical trial processes for compliance and risk analysis;
- Analyse findings of project-specific compliance checks across assigned clinical trial(s).
The ideal candidate brings along the following:
- Higher level of education in a (bio)medical field;
- Knowledge of legislation and regulation, clinical processes and ICH-GCP guidelines;
- A minimum of three years experience as CRA, CTL or CPM;
- Strong command (written and verbal) of English, and by preference Dutch;
- Creative problem solving/out-of-the-box thinking;
- Ability to multitask, prioritise and being stress-resistant.
Besides the opportunity to join an organisation which is strongly growing, focussing on quality and believing in a flat hierarchical structure, the organisation offers the following:
- A competitive base salary, tailored to experience;
- ABP pension (70% employer / 30% employee);
- A yearly bonus arrangement;
- 30 holidays;
- Daily home work allowance;
- Work-from-home budget of EUR 600.
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Associate | Biotechnology
+31 6 51 66 69 96