Clinical Data Manager
An exciting opportunity has arisen for a CDM to join a large biotech in Belgium, you will be responsible for all data management aspects of the assigned clinical studies from initiation til closure ensuring that clinical data completeness is compliant with the local and global regulations.
- Oversee all deliverables of activities outsourced to CROs as outlined in the SOW and described in the Data Management Trial Oversight plan, including, but not limited to:
- Creation of data collection tools (EDC, DTAs for 3rd party vendors, EDC integrations)
- Creation of essential documents (DMP, UAT documents)
- Creation of submission ready clinical data package per regulatory agencies requirements.
- Creation of archival package of clinical data per requirements
- Oversee all activities related to Data Management:
- Ensure that Data Management essential documents are written in a timely manner and of such quality to allow the evaluation of the conduct of a trial and the quality of the data produced
- Facilitate cross-functional review by applicable stakeholders of essential documents and data management deliverables
- Keep track of project plan, budget, metrics and KPIs. Adjust project plan as needed in consultation with Data Management CRO and Clinical Team.
- Create Data Release Plan in consultation with applicable stakeholders and oversee Data Releases (such as for DSMB/IDMC, interim and final locks, updates after lock) as per plan and blinding rules.
- Participate in User Acceptance Testing Activities for the applicable Data Collection Tools
- Perform adequate Quality Control for data completeness and accuracy
- Contribute to the development in lessons learned and shares best practices within the trial and department.
- The CDM will also participate in activities other than study-related:
Skills and Requirements
- Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM best practices
- Experience with tools and systems for managing clinical studies (study progress and metric systems, eCRF systems, metadata repositories)
- Eye for detail, analytical skills
- Able to work effectively within a team matrix as well as independently
- Strong communication and interpersonal skills
- Fluent in English (written and spoken)
- Bachelor's degree or Master's degree - medical, para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.), mathematics or equivalent by experience
- Demonstrated experience in Clinical Data Management
- Experience in managing CROs and vendors is a plus
- Biotech experience is a plus
- Auto-immune and/or orphan disease clinical study background is a plus
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