Ref #: 26741

Employment type: Fixed term - Full-Time

Location: Netherlands

Posted: 19-Feb-2021


The jobholder will be responsible for providing Project Management guidance to study teams, study startup and closeout guidance, migration support, tracking high‐level study milestone information and clinical view refresh when required in the Electronic Data Capture (EDC) Tool.
In his/her area of responsibility, the job holder will be responsible to support continuous improvement framework with respect to systems deployment, project management and enhancements supported by greater partnerships with suppliers, CRO partners and industry user groups.

The jobholder may be responsible for support in systems inspection readiness and provide expertise as necessary for FDA and other health authority inspections.

Key responsibilities:
- Supporting study teams with scheduling migrations
- Maintaining the Trial Data Repository in Medidata Rave
- Database lock activities such as updating user access, clinical view (CV) refreshes
- Database un‐lock activities
- Database archival activities such as removing all user access and turning off clinical views.
- Uploading eCRF guidelines on the FTP server.
- Granting user access to iMedidata and Medidata Rave
- Submitting FTP requests for end users
- Study Team support (internal and external partners) at a platform level for all therapeutic areas by answering ad‐hoc questions.
- Guide study team members to Data Collection Solutions documentation
- Review listings and follow‐up with study team members as appropriate
- May have the responsibility to train or mentor new members in the organization.
- Participate in UAT activities of system upgrades
- Participate in GDCO and cross sector initiatives as assigned
- Assist with vendor management
- Excellent problem solving and decision‐making skills
- Strong planning, organization and project management skills
- Contribute to the Data Collection Solutions team active in the development, implementation, maintenance and continuous improvement of systems supporting GCDO’s end-to-end processes.
- Other tasks as needed


- Minimum of 3 years of experience working within systems covering clinical development in the Pharma sector.
- Knowledge of Electronic Data Capture (EDC) systems with strong working knowledge of iMedidata and Rave is preferred.
- Strong communication skills
- Attention to detail
- Understanding of GCP, ICH, and 21 CFR part 11
Why join the DOCS team of ICON?

Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.

Interested? Please send your CV to: Iris Brouwer (