Data Manager

Clinical Research · Leiden (Hybrid)

Apply for this Job

Description

Are you looking for a job where you can make a difference and work in a non-profit? Would you like to be a part of an ambitious and international organisation on the cutting edge of science? Then this position might be right up your alley.


The EBMT is a non-profit medical and scientific organisation which hosts a unique patient registry providing a pool of data to perform studies and assess new trends. 

 

Our Mission

Save and improve the lives of patients with blood-related disorders.



YOUR MISSION

Perform data management for prospective and commercially funded clinical studies.

Work under the general direction of the Clinical Study Lead and/or Data Manager Lead.

 

 

RESPONSIBILITIES AND TASKS

 

The main responsibilities are:

 

•      Develop and manage systems/tools to organise, collect, enter, clean, report, and monitor large amounts of complex clinical data.

•      Prepare, interpret, analyse, and visualize complex data.

•      Ensure data quality and completeness by performing data quality checks.

•      Review (and generate) study reports, abstracts/manuscripts before submission in collaboration with Marketing Authorisation Holders (MAHs), investigators, statistician and others

•      Integrate data from several sources. 

•      Perform verifications of own work or that of others to ensure conformance with established procedures.

•      Contribute to the optimisation of data processes within the Clinical Study Unit.

 

The other responsibilities may include but are not limited to:

 

•      Develop and maintain all documents and procedures related to the data management aspects of studies in accordance with applicable legislations, regulations and standard operating procedures.

•      Instruct and provide guidance to less experienced staff and data entry clerks.

•      Participate in meetings with internal study team and/or external clients. 

•      Support EBMT Registry staff with the development of Registry data collection forms. May test new software and participate in approval and release process for new software.

•      Review study proposals/protocols, conduct feasibility studies and assessing potential bottlenecks for study conduct.

•      Based on the study protocol, apply practical understanding of the data and data processing methods

•      Create data requests/CRF or surveys. Coordinate data collection with centres, assist with data entry when needed.

Requirements

  • Bachelor’s Degree in bioinformatics, computational sciences, applied mathematics, biomedical sciences or a related field
  • Minimum of 1 year of daily work experience working with R software environment for statistical computing and graphics
  • Minimum of 1 year of work experience in data processing
  • Knowledge and demonstrated experience with relational databases, data integration, analysis and statistics
  • Fluent in English, excellent oral and written skills
  • Ability to produce data in a clear and understandable manner meeting user requirements
  • Ability to work with data of varying levels of quality and validity
  • Ability to prioritise workload and meet deadlines
  • Initiative


NICE-TO-HAVES

  • Master’s Degree in bioinformatics, computational sciences, applied mathematics, biomedical sciences or a related field
  • 2 years of experience in data management
  • Experience working with SPSS syntax or other statistical and programming software
  • Knowledge of data management principles and regulatory requirements for data processing
  • Knowledge of GCP/GVP legislation and regulations applicable to clinical research


WHAT WE OFFER

  • Be part of a non-profit society where you can make a difference
  • Work alongside a multicultural and diverse international team
  • Based in Leiden or surroundings - attendance to EBMT offices 2 days per week and working remotely 3 days.
  • Full-time position (36 hours/week)
  • Flexible working hours (starting from 8am to 10am and finish accordingly).
  • 1 year contract with the possibility of staying with us in the long term
  • 1 month probation period
  • 25 days of vacation per year
  • Salary: 3204 - 3445 euros gross/month (depending on previous experience).


ADDITIONAL BENEFITS (once probation period is over)

  • Travel allowance for commuting on office days
  • An end of the year payment
  • 8% holiday remuneration
  • Some foreign travel
  • Support in training and professional development
  • A pension arrangement with the National Civil Pension Fund
  • You may join our collective health insurance policy (covered by employee)

Location (Hybrid)