TL;DR
Real-World Data Specialist (Medtech): Leading the planning and execution of RWD collection within Expanded Access Programs and non-interventional studies with an accent on data quality, compliance with ICH-GCP, and stakeholder communication. Focus on ensuring the integrity of real-world patient outcomes data and contributing to process improvements.
Location: Hybrid in Amsterdam
Company
hirify.global is a global health tech company using an AI-powered platform to enable earlier and better treatment access for patients worldwide.
What you will do
- Lead RWD collection planning and execution for EAPs and non-interventional studies.
- Manage communications with clients, physicians, and site staff to ensure smooth data collection processes.
- Monitor data quality and proactively address discrepancies or missing information.
- Ensure compliance with ICH-GCP and relevant regulatory guidelines for RWD collection.
- Refine and maintain SOPs, templates, and documentation to improve RWD study processes.
- Collaborate with cross-functional teams to align RWD deliverables with program goals.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
- 2+ years of experience in Data Management, Real-World Data, or Clinical Research.
- Familiarity with electronic data capture (EDC) systems and strong proficiency in Microsoft Office Suite.
- Strong organizational and problem-solving skills, with great attention to detail.
- Understanding of ICH-GCP guidelines (certification preferred).
- English: B2 required.
Culture & Benefits
- Impactful work that helps patients gain access to potentially lifesaving treatments.
- International work environment, scale-up energy, and a flat organizational structure.
- Competitive salary, annual performance bonus, and an Employee Stock Option Plan.
- Great career development opportunities in a fast-growing company, with a learning and development budget.
- Attractive pension plan, with full premium covered by hirify.global.
- Policies to support working parents and unlimited access to professional guidance by certified psychologists via OpenUp.
- Enjoy monthly events hosted by the vibrant Culture Club, as well as an annual company-wide celebration.
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