Clinical Data Manager job in Belgium

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Data Management

Location: Belgium

This vacancy has now expired. Please see similar roles below...

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.

Job Responsibilities

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

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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