Vacancy Project Compliance Manager – Zeist


Organization

For an international, midsized Contract Research Organisation specialising in cardiology, immunology, and neurology, we are looking for a Project Compliance Manager. They are working on several clinical trials and provide answers for today’s clinical drug development challenges. This Contract Research Organisation is operating in 39 countries and has currently more than 140 employees.

This CRO aims to improve healthcare for everyone through tailoring clinical research for each unique study. The core values to which they adhere are scientific, creativity, partnership, focus, and social responsibility. You will be part of a small team surrounded by energetic professionals in an innovative culture that stimulates you to come forward with new ideas. Besides the studies being unique, the role is also quite unique, allowing you to escape the daily rush of clinical research and instead focus on making sure everything and everyone is compliant.

Function

As a Project Compliance Manager, you are responsible for developing, analysing, and initiating updates to standardised clinical trial processes from a compliance point of view. You will ensure that the regulations are properly applied by developing, planning, and executing compliance checks on clinical trial processes following the project-specific compliance management plan. Afterward, you will review the proposed clinical trial processes by 3rd parties for compliance and practical issues and contributing to the risk analysis. You will also create a training program both internally as well as for external partners to ensure the correct implementation of the clinical trial processes. You are constantly interacting with people in and outside the organisation by being the primary contact person for any questions or issues. Last but not least, you will keep track of the maintenance and improvement of the clinical trial processes during each phase. This position allows you to organise your own day, it’s much less ad hoc and you are in charge of judging what has the highest priority. Doing so, giving you a sense of freedom and control over your own time and responsibilities. From here you can grow towards a team lead, project manager or move into quality.

Requirements

We’re looking for someone with the following profile:

  • Minimum 3 years of experience within clinical research, for example: as a CRA, Clinical Team Lead, Clinical Project Manager or another relevant role
  • Completed education of Bachelor’s or Master’s degree in a (bio)medical or life science-related field
  • Fluency in English, spoken and written, preferably also in Dutch
  • Knowledge of ICH-GCP, legislation and regulations, industry practices and guidelines
  • Excellent prioritisation skills and detail-oriented
  • Out-of-the-box-mentality
  • Problem-solving abilities
  • Decisiveness and taking initiative
  • Being enthusiastic and social with a positive attitude

Offer

The organisation can provide you with the following:

  • Opportunity to grow your skills in a dynamic and co-operative organisation
  • Training and support to become a specialist in compliance
  • Standard secondary employment benefits (30 holidays, variable bonus per year by the company performance and individual
  • Possibility to work from home
  • The workweek of max. 40 hours
  • Salary midpoint around €51,000.- depending on experience

Application

If you are interested in this position, please contact is via the information below.

Sharon Lou
Associate | Biotech & Pharma

Mob: +31(0)6-13627820
Tel: +31 23 754 86 60
Mail: s.lou@qtcrecruitment.com
Web: www.qtcrecruitment.com