Clinical Data Manager

Job description

We are looking for a Clinical Data Manager (CDM). The successful candidate will act as a functional expert in the field of Clinical Research Data Management. He/she will be responsible for ensuring accurate and complete data collection for assigned clinical trials in an efficient manner.


The CDM is responsible for all aspects of clinical data management aspects for the assigned global clinical trials from preparation through archiving.

Study responsibilities include:

  • Responsible for directing, leading and overseeing the data management activities of the CRO and responsible for overseeing vendors involved in the assigned clinical trials based on metrics and plan
  • Assist in CRO contract negotiations together with the company’s Clinical Study Manager and other stakeholders
  • Provide input to and/or development of study related materials such as Clinical Study Protocol, Clinical Monitoring Plans, Data Management Plans, eCRF completion guidelines, External Data Reconciliation Plans, SAS Listing Specifications, Lab Data Transfer Plans, etc.
  • Monitor and tracking of patient data entry and query resolution in accordance with agreed timelines
  • Ensure clinical trials are conducted in compliance with ICH-GCP and other applicable legislations related to Data Management activities
  • Review protocol deviations and related data listings for studies to ensure high quality data is provided and identify and resolve structural issues/concerns
  • Conduct QA/QC checks of the data recorded in the clinical database in line with the company’s quality standards
  • Ensure timely collection of CRF documentation for periodic review
  • Contribute to the development and implementation of the quality system for Data Management to ensure efficient processes and the best quality of service across the Biometrics department
  • Proactively identify and resolve issues in the assigned clinical trials and escalate in a timely manner, if needed
  • Assist the Clinical Study Manager in the preparation of study timelines and budget and delivering studies within timelines, scope and budget, aligned with the clinical development plan and quality in line with the company’s quality standards
  • Attend and contribute to Clinical Study Team meetings from Data Management perspective, for the purpose of planning, set-up, conduct and close-out of Clinical Trials
  • Take ownership of quality, timelines and budget aspects related to Data Management for your clinical trials
  • Maintain oversight of the planning, preparation, set-up, testing/validation, conduct, documentation and filing of Data Management processes and systems from external service/data providers, and facilitating collaboration and integration of processes and systems of multiple external service/data providers involved in a clinical trial.

  • Bachelor's degree or university degree - medical, paramedical (biology, Biomedical Sciences, pharmacy, veterinary medicine, etc.), mathematics, or equivalent by experience
  • At least 5 years of experience in Clinical Data Management
  • Excellent communication skills in English (verbal and written)
  • Good knowledge of ICH -GCP and other applicable regulatory guidelines and legislation, and advanced hands-on experience with and knowledge of Clinical Data Management System (s) and supporting software
  • Ability to organize and plan multiple priorities and coordinate external service providers
  • Experience in managing CROs and vendors is a plus

Our offer
  • An attractive salary in line with your experience and skills.
  • Fringe benefits including medical insurance, pension plan and a care plan.
  • A supporting environment.
  • Respect for the life-work balance.
  • Career planning.
  • A focus on professional and personal growth through training and coaching.
  • Room for personal engagement to help shape our company's future.
Contact person

Evelien Van Eecke

Personal profile
Contact details
Van Eecke
Clinical Talent Specialist

Do you want to learn more about Fern Valley? Are you interested in seeing how we can help your company grow? Let's get acquainted. I'll be delighted to hear your story and to share our vision. Experience the personal & open approach of Fern Valley and embark on a journey with us.

+32 476 98 62 94