Clinical Business Analyst/project Manager
il y a 4 jours
**Context**: We are part of a digital clinical operations team responsible for managing various digital solutions in clinical trials, particularly focusing on MyVeeva, a clinical outcomes assessment solution. This role supports and helps configure MyVeeva based on study team requirements and clinical operations. The role involves understanding clinical protocols, design, and requirements to support clinical trials effectively.
**Role Focus**:
- Business operations/clinical operations side.
- Clinical project management/clinical study management during the clinical operations phase.
- Not heavily IT tech-oriented (no programming, mínimal testing) - requires understanding components/digital solutions.
- Collaboration with clinical study team members (study operations).
**Tasks/Daily Activities**:
- Oversee the study implementation.
- Requirements gathering (interpret the study protocol design and align it with our solutions).
- Project management/project planning.
- Understanding IRB submissions, translations, and certifications processes for patient-facing solutions.
- Working with license products.
- Scale existing product/solution (MyVeeva) to meet study objectives (eConsent, patient-reported outcomes, data capture at sites).
**Must-Haves**:
- Understanding of clinical operations (particularly Phases II & III).
- Experience with digital solution implementations in clinical studies (patient-reported outcomes and clinician-reported outcomes).
- Project management experience.
- Familiarity with setting up and implementing clinical studies.
- Experience with digital solutions in clinical studies (eConsent, patient-reported outcomes, clinician-reported outcomes, eDiaries, processes).
- Experience with User Acceptance Testing in clinical studies.
- Project management experience.
**Nice to Have**:
- Experience with Veeva solutions.
**Interview Process**:
- Two rounds of interviews.
Work Location: Hybrid remote in 1000 Brussel
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