Clinical Data Manager

The team consists of a Manager Data Management, 1 Senior Data Manager, 3 Data Managers, 4 junior Data Managers and a Statistical Officer. You will be reporting to the Manager Data Management. You are encouraged to share your ideas to the further development of the department. You represent data management in the study team of the study(s) possibly in diverse therapeutic areas you are responsible for, and you ensure that all data management activities are performed with high quality from the beginning of the study. Besides this you also represent the team within the company (cross team) and when necessary you also have contact with external parties.

We preferably are looking for an experienced (Senior) Data Manager who is next to his/her Data Management tasks also able to maintain oversight on multiple projects and is able to be the (first) internal point of contact for the other Data Managers.

1. Represents Data Management in (internal) study teams and within the company;
2. Coaches and supports Junior Data Manager and other (project) Data Managers on project related tasks;
3. Serves as point of contact for external parties such as vendor(s) for Central Laboratory or Investigational Medicinal Product (IMP) vendor and sponsor(s);
4. Designs, manages and delivers a clinical database within the agreed timeframes and adheres to all relevant quality standards;
5. Organizes data capture, quality and management processes to safeguard study data integrity and quality in full accordance with the Standard Operating Procedures ánd international laws and guidelines;
6. Keeps oversight on relevant Data Management activities within a project, as specified in the Data Management Plan;
7. Organises and distributes study data to facilitate statistical analysis and reporting;
8. Contributes to process improvements, e.g. professionalization of work activities, methods of working, implementation of new legislation and regulations.
9. Supports or even ensures the implementation of the latest Data Quality requirements to the clinical trial processes, including to business processes;
10. Assists the IT department in validating the computerized clinical study management systems;
11. Provides input for Data management services cost proposal and complies with project budgets (for Data Management activities).

1. Higher level of education preferably in (bio)medical, scientific or computer science;
2. At least 3 years of relevant experience, preferably within the Food, Health or Clinical Research sector;
3. At least 3 years of relevant experience in working with tracking/analysis software, Electronic Data Capture systems and computer systems;
4. For the position with extra tasks: experienced Data Manager with good overview skills and experience / affinity with coaching and mentoring colleagues of more junior level;
5. Knowledge of FDA, ICH GCP, GCDMP and related regulatory requirements;
6. Knowledge of CDISC, SDTM is an advantage;
7. Fluency in English; preferably also in Dutch;
8. Independent, proactive, process orientated and team player;
9. Good analytical and communicative skills.

An open culture in an innovative and dynamic environment with inspiring colleagues and good working conditions. An environment where you have room to be creative, take initiative and have direct influence on the way we work. Good opportunities for (personal) growth and further development.