Ref #: 26638

Employment type: Permanent - Full-Time

Location: Antwerp area, Belgium

Posted: 03-Feb-2021


The services hold a responsibility for implementation and maintenance of digital health systems
supporting clinical development activities within the Global Development department. The incumbent
will be required to provide subject matter expertise in system implementation, validation, maintenance
and issue escalation. In addition, it includes participation in/lead operational strategy projects.
The services require to work closely with other team members to ensure system impact is assessed
and mitigation strategies are in place where applicable. A clear understanding on the needs of clinical
trials/programs and internal or external stakeholders.

Responsibilities include:

System Support
* Follow-up and support releases for the technologies/systems in use
* User acceptance testing to be performed for each respective technology/vendor systems in use
* Identify/write system test scripts with the highest quality
* Review of System Development Lifecycle (SDLC) documentation
* Evaluate Change Control Plan/Report as appropriate in close collaboration with IT
* Support system UAT automation where needed
* Work with IT to re-test defects after a fix has been applied, including regression testing
* Support integrations landscape and validation needs
* Support vendor oversight, which can include incident/problem management, device provisioning
follow-up and escalate as needed

System Operational Strategy
* Participate in strategy projects implementing new solutions
* Ensure implementation follows the landscape strategy
* Create and review documentation requirements
* Interact with key internal and/or external stakeholders
* Align and support system requirements
* Interact with Business and obtain the Business Scenarios

* Services rendered will adhere to applicable SOPs, WIs, policies, all applicable local laws and regulations, ICH-GCP, etc
* Complies with relevant training requirements
* Protect the rights of others; protect privacy and company assets, particularly information as the key asset
* Maintain adequate communication with relevant parties within and outside the company
* Regularly update information in applicable systems and templates
* Contribute to the development and improvement of departmental procedures and processes and templates in the scope of the company’s effort towards continuous quality improvement
* Maintain quality standards and timelines that are consistent with business needs
* Organize multiple complex priorities and projects and use a range of techniques to identify and resolve trial-related problems
* Change management – understand how to cope with change and influence/motivate others to deal with change

Required experience and qualifications:

* Bachelor’s degree (University degree) or equivalent education required
* At least 2-3 years of operational experience in clinical trials with a pharmaceutical company and/or a CRO
* IT project management is a strong plus
* Demonstrated knowledge of clinical development processes, global clinical operations, and strategic planning is required
* Demonstrated knowledge of industry best practices for vendor management
* Good understanding of therapeutic areas
* Experience with self service provides, digital platforms and technologies
* Strong IT skills in appropriate software and company systems
* Demonstrate a passion for digital technologies and how these are implemented in clinical studies
* Excellent in speaking and writing in English (Dutch is a plus). Effective communication skills, oral and written
* Good presentational and motivational skills

Why join the DOCS team at 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.