We are looking for a unique individual to strengthen our team.
As the IT Solution Expert, Digital Clinical Trials, you will Drive and lead global clinical development, clinical trial IT activities with a focus on innovative digital / progressive solutions.
The role is based in one of our key global branches in the US or EU (RTP, NC. Brussels, Belgium. Slough, UK)
Your main responsibilities
As the IT Solution Expert - Digital Clinical Apps, you will:
- Innovate new solutions for data capture (eSource) and patient engagement in clinical trials that fundamentally changes the status-quo in clinical development.
- Key interest areas include but not limited to: apps, devices, sensors, patient experience, e-diaries, electronic patient reported outcomes (ePRO), Clinician Reported Outcomes (ClinRO) eConsent and virtual clinical trials.
- Use our internal digital tools to support the process around: eCOA design, licensing, copyright holder and vendor management.
- Maintain eCOA Library database and identify COAs to develop in the client eCOA library
- Connect with stakeholders to drive ideation through execution to a final product. Work through challenges, create a product/prototype using agile techniques that can be handed off with close coordination to a DevOps team for implementation while maintaining full accountability & leadership for delivery.
- Focuses on relationship between study lead and technical roles, ensuring accurate and decisive direction is provided to the SDT (solution development team) on day-to-day basis
- Ensure GxP compliance and process alignment in collaboration with core stakeholders: GCSO, Clinical Development (ePRO), Patient Safety, Clinical QA, etc…
- Responsible for various system configurations as part of the enablement of studies leveraging the digital technology
You see yourself immediately when reading…
- Expert: You are passionate about technology and application of it in the clinical development space. 3+ years experience in the pharmaceutical industry in clinical development with project responsibility in the eSource space. Expert in the eCOA space and it's applicability to clinical trials using a digital eCOA platform.
- Teamplayer: You are a cross functional team player and leader at the same time (should know when to act as a team player and when to act as a leader) in a globally diverse cultural environment. Business analysis, Agile development, rapid prototypes and product & project management methodology.
- Initiative: You engage patients, partners and stakeholders in value creation. Co-create patient, partner and stakeholder interactions that will increase the client's transparency and build trust, while bringing value to patients on their healthcare journey.
- Quality: Understanding and experience with GCP, system validation and 21 CFR 11 and it's application in the digital space. Your attention to detail leads to a delightful user experience.
- Market our value: You are able to qualify and quantify the benefits of solutions/systems/products.