Digital Clinical Trial Lead

For one of our pharmaceutical clients, we are looking for a Digital Clinical Trial Lead. In the role of Digital Clinical Trial Lead, you will be part of the department which performs clinical studies for all pharmaceutical products of our client that are under development. The clinical studies are often global studies, and the data generated in these studies are collected to become part of the marketing authorization application dossier which is prepared and submitted by Global Regulatory Affairs. The therapeutic areas are immunology, Oncology, Infectious Diseases, Cardiovascular disease and CNS.

From the digital technology aspect, you will be working specifically on the Integrated Smart Trial Engagement Program (iSTEP). This is a program combining smart technologies (smart packages, smart phones, scanning devices) with an integrated platform, and is designed to enable personalized end-to-end patient engagement plus automate clinical supplies and data management in clinical studies. Not only will iSTEP transform the way clinical trials are done, this initiative has also been a testimonial of excellent collaboration, creativity and dedication of a “first-class” cross-departmental and cross-sector team, as well as state-of-art external partnerships with platform, digital and package vendors.

Responsibilities

• Execute the iSTEP program on one or more clinical studies from within Enabling Business Information Solutions (EBIS), a department who supports operationalizing new technologies into the business
• Lead all iSTEP activities needed for the clinical study ensuring study team oversight & engagement (change management) as also providing explanation, training, escalation, … where needed.
• Represent the company and the organization adequately to the customers and other external parties
• 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
• Comply with ICHGCP and all applicable local laws and regulations.
• Report (suspicion of) fraud or scientific/ethical misconduct as appropriate.
• 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.

• Experience and proficiency in the conduct and management of clinical trials
• Thorough understanding of clinical drug development and regulatory procedures and processes
• Ability to manage and support the activities of the Local trial and Site Managers and other local staff assigned to the trials for which responsible
• Change management experience 
• Passion for digital technologies and how these are implemented in clinical studies
• Ability to organize multiple complex priorities and projects and use a range of techniques to identify and resolve trial related problems
• Coaching understand and apply coaching theory and skills and select appropriate coaching structure to suit individual needs
• Fluent in English 
• Possess a comprehensive knowledge of company SOPs, ICHGCP and local national regulations

• Challenging projects based on your interests and skills
• Personal follow-up and clear, transparent communication both before and after commencement of employment
• Possibility to follow extra training
• Inspiring network events and legendary after work drinks
• Strong network of industry leading clients
• Expertise within IT, Engineering and Life Sciences
• A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees

Bezoek pauwelsconsulting.com voor meer informatie over de vacature Digital Clinical Trial Lead of solliciteer online op de vacature Digital Clinical Trial Lead.

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